FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
K Number: K921227
·
Decision May 29, 1992
Classifications
1
FEI Numbers
570
Registration Numbers
570
Same Product Code
87
Applicant Total
3
Review Days
77
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Basic Information
- Device Name
- TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE
- K Number
- K921227
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4014
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Courtaulds Fibers, Inc.
- Date Received
- March 13, 1992
- Decision Date
- May 29, 1992
- Product Code
- NAB
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| NAB | Gauze / Sponge,Nonresorbable For External Use | FDA class 1 | General, Plastic Surgery |
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