The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons with the FDA for Germicidal Cloth.
Device ID | K974304 |
510k Number | K974304 |
Device Name: | GERMICIDAL CLOTH |
Classification | Disinfectant, Medical Devices |
Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 5035 MANCHESTER AVE. St. Louis, MO 63110 |
Contact | Mike Ebers |
Correspondent | Mike Ebers CONVATEC, A DIVISION OF E.R. SQUIBB & SONS 5035 MANCHESTER AVE. St. Louis, MO 63110 |
Product Code | LRJ |
CFR Regulation Number | 880.6890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-11-17 |
Decision Date | 1998-01-13 |
Summary: | summary |