The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for Tecnol Island Wound Dressing.
| Device ID | K954033 |
| 510k Number | K954033 |
| Device Name: | TECNOL ISLAND WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | TECNOL MEDICAL PRODUCTS, INC. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 -5322 |
| Contact | Pam Liberto |
| Correspondent | Pam Liberto TECNOL MEDICAL PRODUCTS, INC. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 -5322 |
| Product Code | MGP |
| 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 | 1995-08-28 |
| Decision Date | 1995-09-22 |