The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Ultec Thin Hydrocolloid Dressing.
| Device ID | K952071 |
| 510k Number | K952071 |
| Device Name: | ULTEC THIN HYDROCOLLOID DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | K. Michael Kroehnke |
| Correspondent | K. Michael Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-02 |
| Decision Date | 1995-06-22 |