The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Dutex Gauze Bandage.
Device ID | K946326 |
510k Number | K946326 |
Device Name: | DUTEX GAUZE BANDAGE |
Classification | Gauze/sponge, Internal |
Applicant | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
Contact | Angelo Guerriero |
Correspondent | Angelo Guerriero DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-22 |
Decision Date | 1995-01-24 |