The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Dumex Pak-its-absorbasalt Cotton Gauze Packing.
| Device ID | K980777 |
| 510k Number | K980777 |
| Device Name: | DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Contact | Sharmini Atheray, M.sc |
| Correspondent | Sharmini Atheray, M.sc DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-02 |
| Decision Date | 1998-05-04 |