510k
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538
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360
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1323
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243
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957
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2175
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2038
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126
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97
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462
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433
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2830
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515
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2403
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Polymer Patient Examination Glove
407
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System, Image Processing,...
381
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358
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Powered Laser Surgical Instrument
351
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Electrosurgical, Cutting &...
301
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System, Imaging, Pulsed Doppler,...
284
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Automated Radiological Image...
275
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Plate, Fixation, Bone
269
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Orthopedic Stereotaxic Instrument
226
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Intervertebral Fusion Device...
209
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Custom Pack Reliability
Medical Device Manufacturer
·
US , Orlando , FL
Custom Pack Reliability - FDA 510(k) Cleared Devices
21 submissions
·
21 cleared
·
Since 1996
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Custom Pack Reliability
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 04, 1996
CPR HEART PACK
K960209
·
GAW
General & Plastic Surgery
·
79d
Cleared
Mar 28, 1996
CPR LAP SPONGES
K960236
·
GDY
General & Plastic Surgery
·
72d
Cleared
Mar 22, 1996
CPR GENERAL SURGERY TRAY
K960241
·
LWI
General & Plastic Surgery
·
66d
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21
General Hospital
12
Gastroenterology & Urology
3
General & Plastic Surgery
3
Obstetrics & Gynecology
2
Anesthesiology
1