The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Dupaque Sponge.
| Device ID | K941217 |
| 510k Number | K941217 |
| Device Name: | DUPAQUE SPONGE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Contact | Bill Goodwin |
| Correspondent | Bill Goodwin DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-14 |
| Decision Date | 1994-04-21 |