The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for Sparta Wet Dressing, Sodium Chloride.
| Device ID | K922729 |
| 510k Number | K922729 |
| Device Name: | SPARTA WET DRESSING, SODIUM CHLORIDE |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| Applicant | SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Contact | Carleton F Kimber |
| Correspondent | Carleton F Kimber SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Product Code | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-05 |
| Decision Date | 1992-11-23 |