The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Sterile Gauze Pk Strips Sat W/carr Gel Wound Dress.
| Device ID | K915002 |
| 510k Number | K915002 |
| Device Name: | STERILE GAUZE PK STRIPS SAT W/CARR GEL WOUND DRESS |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CARRINGTON LABORATORIES, INC. POST BOX 569003 Dallas, TX 75356 |
| Contact | Eric Moore |
| Correspondent | Eric Moore CARRINGTON LABORATORIES, INC. POST BOX 569003 Dallas, TX 75356 |
| 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 | 1991-11-07 |
| Decision Date | 1992-01-31 |