The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Carraklenz And Ultraklenz.
| Device ID | K022670 |
| 510k Number | K022670 |
| Device Name: | CARRAKLENZ AND ULTRAKLENZ |
| Classification | Dressing, Wound, Drug |
| Applicant | CARRINGTON LABORATORIES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mc-namara-culinane |
| Correspondent | Mary Mc-namara-culinane CARRINGTON LABORATORIES, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| 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 | 2002-08-12 |
| Decision Date | 2002-10-17 |
| Summary: | summary |