510k
Database
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Anesthesiology
527
Cardiovascular
1636
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2157
General Hospital
2020
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126
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92
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8
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459
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948
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430
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272
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2795
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52
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515
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2370
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155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
278
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Steripak, Ltd.
Medical Device Manufacturer
·
GB , Runcorn, Cheshire
Steripak, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
1 cleared
·
Since 1998
2
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - Steripak, Ltd.
General & Plastic Surgery
✕
1
devices
1-1 of 1
Filters
Cleared
Mar 05, 1998
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE
K972185
·
FRO
General & Plastic Surgery
·
268d
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2
General & Plastic Surgery
1
Anesthesiology
1