The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Enteric Tube Guide.
Device ID | K790872 |
510k Number | K790872 |
Device Name: | ENTERIC TUBE GUIDE |
Classification | Guide, Surgical, Instrument |
Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FZX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-05-07 |
Decision Date | 1979-05-23 |