The following data is part of a premarket notification filed by 3m Company with the FDA for Tegaderm Transparent Dressing.
Device ID | K811291 |
510k Number | K811291 |
Device Name: | TEGADERM TRANSPARENT DRESSING |
Classification | Tape And Bandage, Adhesive |
Applicant | 3M COMPANY 8124 PACIFIC AVE. White City, OR 97503 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-11 |
Decision Date | 1981-06-02 |