FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
K Number: K962234
·
Decision Jun 28, 1996
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
3
Review Days
17
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Basic Information
- Device Name
- STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
- K Number
- K962234
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Howard Medical Co.
- Date Received
- June 11, 1996
- Decision Date
- June 28, 1996
- Product Code
- EFQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
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