The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for 3m Tegasorb Thin Hydrocolloid Dressing.
Device ID | K924280 |
510k Number | K924280 |
Device Name: | 3M TEGASORB THIN HYDROCOLLOID DRESSING |
Classification | Bandage, Liquid |
Applicant | 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Contact | Suzanne M Danielson |
Correspondent | Suzanne M Danielson 3M HEALTH CARE, LTD. 3M CENTER, BLDG. 275-3E-08 P.O. BOX 33275 St. Paul, MN 55133 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-25 |
Decision Date | 1993-05-12 |