The following data is part of a premarket notification filed by G.d. Searle And Co. with the FDA for Enteral & Nasogastric Sol. Admin. Set.
Device ID | K800815 |
510k Number | K800815 |
Device Name: | ENTERAL & NASOGASTRIC SOL. ADMIN. SET |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | G.D. SEARLE AND CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-11 |
Decision Date | 1980-07-21 |