The following data is part of a premarket notification filed by Tecnol Medical Products, Inc. with the FDA for Tecnol Saline Wet Dressing.
Device ID | K954243 |
510k Number | K954243 |
Device Name: | TECNOL SALINE WET 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 (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-11 |
Decision Date | 1995-11-29 |