The following data is part of a premarket notification filed by Iberhospitex, S.a. with the FDA for Oper-film-adhesive Membrane.
| Device ID | K881936 |
| 510k Number | K881936 |
| Device Name: | OPER-FILM-ADHESIVE MEMBRANE |
| Classification | Dressing, Wound, Drug |
| Applicant | IBERHOSPITEX, S.A. AVENIDA DE CATALUNYA, NO. 4 08185 LLISSA DE VALL Barcelona, Spain, ES |
| Contact | Lopez Rodriguez |
| Correspondent | Lopez Rodriguez IBERHOSPITEX, S.A. AVENIDA DE CATALUNYA, NO. 4 08185 LLISSA DE VALL Barcelona, Spain, ES |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-08-31 |