The following data is part of a premarket notification filed by Sparta Surgical Corp. with the FDA for Sparta Hydrogel Wound Dressing.
| Device ID | K945313 |
| 510k Number | K945313 |
| Device Name: | SPARTA HYDROGEL WOUND DRESSING |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Contact | C F Kimber |
| Correspondent | C F Kimber SPARTA SURGICAL CORP. 368 FAIRVIEW AVE. P.O. BOX 268 Hammonton, NJ 08037 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1995-01-12 |