FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
GENERAL USE SYNTHETIC SPONGE (STERILE)
K Number: K955527
·
Decision Feb 5, 1996
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
270
Applicant Total
3
Review Days
63
Basic Information
- Device Name
- GENERAL USE SYNTHETIC SPONGE (STERILE)
- K Number
- K955527
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- IGENICS, INC.
- Date Received
- December 4, 1995
- Decision Date
- February 5, 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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