FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRAPES, DISPOSABLE SURGICAL
K Number: K782051
·
Decision Mar 21, 1979
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
1
Review Days
103
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Basic Information
- Device Name
- DRAPES, DISPOSABLE SURGICAL
- K Number
- K782051
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Marco Mfg.
- Date Received
- December 8, 1978
- Decision Date
- March 21, 1979
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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