The following data is part of a premarket notification filed by Sarasota Medical Products, Inc. with the FDA for Stay Fresh Hydrocolloid Dressing.
| Device ID | K151186 |
| 510k Number | K151186 |
| Device Name: | Stay Fresh Hydrocolloid Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | SARASOTA MEDICAL PRODUCTS, INC. 1451 SARASOTA CENTER BLVD. Sarasota, FL 34241 |
| Contact | Walter F. Leise |
| Correspondent | Walter F. Leise SARASOTA MEDICAL PRODUCTS, INC. 1451 SARASOTA CENTER BLVD. Sarasota, FL 34241 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-05-04 |
| Decision Date | 2015-11-27 |
| Summary: | summary |