The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Carrington Dermal Wound Gel.
| Device ID | K894541 |
| 510k Number | K894541 |
| Device Name: | CARRINGTON DERMAL WOUND GEL |
| Classification | Dressing, Wound, Drug |
| Applicant | CARRINGTON LABORATORIES, INC. 9200 CARPENTER FREEWAY Dallas, TX 75247 |
| Contact | Bill H Mcanalley |
| Correspondent | Bill H Mcanalley CARRINGTON LABORATORIES, INC. 9200 CARPENTER FREEWAY Dallas, TX 75247 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-20 |
| Decision Date | 1989-11-30 |