510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1636
Chemistry
358
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
947
General & Plastic Surgery
2157
General Hospital
2023
Hematology
126
Immunology
95
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8
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459
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949
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430
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272
Orthopedic
2796
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52
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515
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2371
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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
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Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
279
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Holopack International, LP
Medical Device Manufacturer
·
US , Columbia , SC
Holopack International, LP - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 1997
Official Website
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Holopack International, LP
Anesthesiology
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 21, 1998
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP
K974056
·
CAF
Anesthesiology
·
86d
Cleared
Aug 28, 1997
SODIUM CHLORIDE INHALATION SOLUTION, USP
K972466
·
CAF
Anesthesiology
·
58d
Cleared
Aug 28, 1997
STERILE WATER FOR INHALATION, USP
K972467
·
CAF
Anesthesiology
·
58d
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3
Anesthesiology
3