The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Carasyn Hydrogel Wound Products.
| Device ID | K961758 |
| 510k Number | K961758 |
| Device Name: | CARASYN HYDROGEL WOUND PRODUCTS |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CARRINGTON LABORATORIES, INC. 2001 WALNUT HILL LN. Irving, TX 75038 |
| Contact | Dennis R Sparkman |
| Correspondent | Dennis R Sparkman CARRINGTON LABORATORIES, INC. 2001 WALNUT HILL LN. Irving, TX 75038 |
| 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 | 1996-05-03 |
| Decision Date | 1996-07-11 |
| Summary: | summary |