The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Aloe Therapy Oral Rinse.
| Device ID | K983182 |
| 510k Number | K983182 |
| Device Name: | ALOE THERAPY ORAL RINSE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | CARRINGTON LABORATORIES, INC. PO BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith CARRINGTON LABORATORIES, INC. PO BOX 4341 Crofton, MD 21114 |
| 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 | 1998-09-11 |
| Decision Date | 1998-12-10 |