The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Deseret Catheter Dressing.
Device ID | K812073 |
510k Number | K812073 |
Device Name: | DESERET CATHETER DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
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 | 1981-07-21 |
Decision Date | 1981-10-06 |