The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Dumex Pak-its Non-woven Dressing Impregnated Sith Sodium Chloride (hypertonic).
| Device ID | K980863 |
| 510k Number | K980863 |
| Device Name: | DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC) |
| Classification | Bandage, Liquid |
| Applicant | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Contact | Sharmini Atheray |
| Correspondent | Sharmini Atheray DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-05 |
| Decision Date | 1998-05-11 |