The following data is part of a premarket notification filed by Entech, Inc. with the FDA for Entube-meer And Meer Feeding Tube Bridle System.
Device ID | K873343 |
510k Number | K873343 |
Device Name: | ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | ENTECH, INC. ROUTE 22 EAST Lebanon, NJ 08833 |
Contact | Laurence A Potter |
Correspondent | Laurence A Potter ENTECH, INC. ROUTE 22 EAST Lebanon, NJ 08833 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-19 |
Decision Date | 1987-12-07 |