The following data is part of a premarket notification filed by Industrias Palex C/o Dma Med-chem Corp. with the FDA for Ulcuflex Hydroculloid Dressing.
| Device ID | K920367 |
| 510k Number | K920367 |
| Device Name: | ULCUFLEX HYDROCULLOID DRESSING |
| Classification | Bandage, Liquid |
| Applicant | INDUSTRIAS PALEX C/O DMA MED-CHEM CORP. JUAN SEBASTIAN BACH 12 08021 BARCELONA, DIRECCION Postal: Apartado 1940, ES |
| Contact | Arcadi Prieto |
| Correspondent | Arcadi Prieto INDUSTRIAS PALEX C/O DMA MED-CHEM CORP. JUAN SEBASTIAN BACH 12 08021 BARCELONA, DIRECCION Postal: Apartado 1940, ES |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-28 |
| Decision Date | 1992-03-26 |