The following data is part of a premarket notification filed by Biochem International, Inc. with the FDA for Sensomat Sidearm Adapter.
Device ID | K790597 |
510k Number | K790597 |
Device Name: | SENSOMAT SIDEARM ADAPTER |
Classification | Accessories, Catheter |
Applicant | BIOCHEM INTERNATIONAL, INC. 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 | 1979-03-26 |
Decision Date | 1979-07-10 |