The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Carrasyn Hydrogel Wound Dressing,carragauze Pads,carragauze Strips,carrasorb M Fdg.
| Device ID | K962218 |
| 510k Number | K962218 |
| Device Name: | CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CARRINGTON LABORATORIES, INC. 1300 EAST ROCHELLE BLVD. Irving, TX 75062 |
| Contact | Dennis R Sparkman, Ph.d. |
| Correspondent | Dennis R Sparkman, Ph.d. CARRINGTON LABORATORIES, INC. 1300 EAST ROCHELLE BLVD. Irving, TX 75062 |
| Product Code | MGQ |
| 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 | 1996-06-10 |
| Decision Date | 1996-09-12 |
| Summary: | summary |