FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇪🇸 Spain
OPER-FILM-ADHESIVE MEMBRANE
K Number: K881936
·
Decision Aug 31, 1988
Classifications
1
FEI Numbers
502
Registration Numbers
502
Same Product Code
106
Applicant Total
3
Review Days
114
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Basic Information
- Device Name
- OPER-FILM-ADHESIVE MEMBRANE
- K Number
- K881936
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Iberhospitex, S.A.
- Date Received
- May 9, 1988
- Decision Date
- August 31, 1988
- 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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