The following data is part of a premarket notification filed by Fountain Pharmaceuticals, Inc. with the FDA for Redi-release Absorbent Dressing.
| Device ID | K904604 |
| 510k Number | K904604 |
| Device Name: | REDI-RELEASE ABSORBENT DRESSING |
| Classification | Beads, Hydrophilic, For Wound Exudate Absorption |
| Applicant | FOUNTAIN PHARMACEUTICALS, INC. 11201 CONCEPT BLVD. SUITE A Largo, FL 34643 |
| Contact | W Fountain |
| Correspondent | W Fountain FOUNTAIN PHARMACEUTICALS, INC. 11201 CONCEPT BLVD. SUITE A Largo, FL 34643 |
| Product Code | KOZ |
| CFR Regulation Number | 878.4018 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-10 |
| Decision Date | 1991-01-07 |