The following data is part of a premarket notification filed by Warner-lambert Co. with the FDA for Deseret Offset Prn Adapter.
Device ID | K821245 |
510k Number | K821245 |
Device Name: | DESERET OFFSET PRN ADAPTER |
Classification | Accessories, Catheter |
Applicant | WARNER-LAMBERT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KGZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-29 |
Decision Date | 1982-05-13 |