The following data is part of a premarket notification filed by Iberhospitex, S.a. with the FDA for Sanifix.
| Device ID | K883983 |
| 510k Number | K883983 |
| Device Name: | SANIFIX |
| Classification | Tape And Bandage, Adhesive |
| 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 | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1988-12-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SANIFIX 73571357 1403188 Dead/Cancelled |
KEUCO AG 1985-12-02 |