The following data is part of a premarket notification filed by Dumex Medical Surgical Products, Ltd. with the FDA for Sterile Water & Sterile 0.9% Sodium Chloride.
| Device ID | K992732 |
| 510k Number | K992732 |
| Device Name: | STERILE WATER & STERILE 0.9% SODIUM CHLORIDE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Contact | Sam Lakhani |
| Correspondent | Sam Lakhani DUMEX MEDICAL SURGICAL PRODUCTS, LTD. 104 SHORTING ROAD Toronto, Ontario, CA M1s 3s4 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-13 |
| Decision Date | 2000-04-20 |