The following data is part of a premarket notification filed by 3m Company with the FDA for Tegaderm Brand Transparent Dressing Series 16xx.
Device ID | K901845 |
510k Number | K901845 |
Device Name: | TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX |
Classification | Tape And Bandage, Adhesive |
Applicant | 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Contact | Charles W Opp |
Correspondent | Charles W Opp 3M COMPANY CHEMOLITE BLVD. & WASHINGTON CITY RD. 19 Cottae Grove, MN 55016 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-24 |
Decision Date | 1990-07-23 |