The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Radiacare Oral Wound Rinse.
| Device ID | K964852 |
| 510k Number | K964852 |
| Device Name: | RADIACARE ORAL WOUND RINSE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CARRINGTON LABORATORIES, INC. P.O. BOX 168128 Irving, TX 75061 -8128 |
| Contact | Dennis R Sparkman, Ph.d. |
| Correspondent | Dennis R Sparkman, Ph.d. CARRINGTON LABORATORIES, INC. P.O. BOX 168128 Irving, TX 75061 -8128 |
| 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 | 1996-12-03 |
| Decision Date | 1997-03-03 |
| Summary: | summary |