The following data is part of a premarket notification filed by Wells Lamont Corp. with the FDA for Wells Lamont Handages/med Wrap Dressings.
Device ID | K925937 |
510k Number | K925937 |
Device Name: | WELLS LAMONT HANDAGES/MED WRAP DRESSINGS |
Classification | Bandage, Liquid |
Applicant | WELLS LAMONT CORP. 6640 WEST TOUHY AVE. Niles, IL 60714 |
Contact | Ben J Birs |
Correspondent | Ben J Birs WELLS LAMONT CORP. 6640 WEST TOUHY AVE. Niles, IL 60714 |
Product Code | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-24 |
Decision Date | 1993-08-09 |