The following data is part of a premarket notification filed by Entech, Inc. with the FDA for Entech Enteral Pump And Set.
Device ID | K873444 |
510k Number | K873444 |
Device Name: | ENTECH ENTERAL PUMP AND SET |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-27 |
Decision Date | 1987-11-02 |