The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Enteral Feeding Pump 14-800 Series.
Device ID | K843168 |
510k Number | K843168 |
Device Name: | ENTERAL FEEDING PUMP 14-800 SERIES |
Classification | Pump, Infusion |
Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. P.O. BOX 1700 35 INDUSTRIAL PARKWAY Somerville, NJ 08876 |
Contact | Manlulu |
Correspondent | Manlulu BIOSEARCH MEDICAL PRODUCTS, INC. P.O. BOX 1700 35 INDUSTRIAL PARKWAY Somerville, NJ 08876 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-13 |
Decision Date | 1984-10-24 |