The following data is part of a premarket notification filed by Fountain Pharmaceuticals, Inc. with the FDA for Sorbex(tm) Soft Sponge.
| Device ID | K895654 |
| 510k Number | K895654 |
| Device Name: | SORBEX(TM) SOFT SPONGE |
| Classification | Dressing, Wound, Drug |
| Applicant | FOUNTAIN PHARMACEUTICALS, INC. P.O. BOX 51863 Knoxville, TN 37950 |
| Contact | W Fountain |
| Correspondent | W Fountain FOUNTAIN PHARMACEUTICALS, INC. P.O. BOX 51863 Knoxville, TN 37950 |
| 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 | 1989-09-20 |
| Decision Date | 1990-02-20 |