FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MULTIPLE
K Number: K831204
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
2
Review Days
229
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Basic Information
- Device Name
- MULTIPLE
- K Number
- K831204
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Derma-Lock Medical Corp.
- Date Received
- April 13, 1983
- Decision Date
- November 28, 1983
- 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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Other Clearances by Derma-Lock Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K874291 | EPI-LOCK T.M. PRIMADERM | Nov 10, 1987 | Substantially Equivalent for Some Indications |