The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Point Of Use Sharps A Gator.
Device ID | K943892 |
510k Number | K943892 |
Device Name: | POINT OF USE SHARPS A GATOR |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
Contact | George Austria |
Correspondent | George Austria DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-09 |
Decision Date | 1994-12-02 |