The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for 100% Cotton Absorbent Towel.
Device ID | K860248 |
510k Number | K860248 |
Device Name: | 100% COTTON ABSORBENT TOWEL |
Classification | Drape, Surgical |
Applicant | DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
Contact | Robert T Horan |
Correspondent | Robert T Horan DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-24 |
Decision Date | 1986-02-19 |