FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
OPSITE WOUND DRESSING
K Number: K852211
·
Decision Jul 23, 1985
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
529
Review Days
63
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Basic Information
- Device Name
- OPSITE WOUND DRESSING
- K Number
- K852211
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Smith & Nephew, Inc.
- Date Received
- May 21, 1985
- Decision Date
- July 23, 1985
- Product Code
- NAD
- 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 |
|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | FDA class 1 | General, Plastic Surgery |
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