The following data is part of a premarket notification filed by 3m Company with the FDA for 3m Tegasorb Thin Hydrocolloid Dressing.
Device ID | K982892 |
510k Number | K982892 |
Device Name: | 3M TEGASORB THIN HYDROCOLLOID DRESSING |
Classification | Bandage, Liquid |
Applicant | 3M COMPANY 3M-CENTER BUILDING 275-3E-08 St. Paul, MN 55144 |
Contact | Anna E Mcright |
Correspondent | Anna E Mcright 3M COMPANY 3M-CENTER BUILDING 275-3E-08 St. Paul, MN 55144 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-17 |
Decision Date | 1998-10-26 |
Summary: | summary |