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 |