The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Dupad, Dupad W/abdom. Pad, Dumex Abdom. Pad, Combo Dressing Roll/combine Dressing Roll.
| Device ID | K960815 |
| 510k Number | K960815 |
| Device Name: | DUPAD, DUPAD W/ABDOM. PAD, DUMEX ABDOM. PAD, COMBO DRESSING ROLL/COMBINE DRESSING ROLL |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-28 |
| Decision Date | 1996-04-29 |