The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Duflex Conforming Bandage (sterile/non-sterile).
| Device ID | K945830 |
| 510k Number | K945830 |
| Device Name: | DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE) |
| 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 | 1994-11-29 |
| Decision Date | 1995-01-11 |