The following data is part of a premarket notification filed by Biosearch Medical Products, Inc. with the FDA for Biosearch 3600 Entri Feeding Pump.
Device ID | K883587 |
510k Number | K883587 |
Device Name: | BIOSEARCH 3600 ENTRI FEEDING PUMP |
Classification | Pump, Infusion |
Applicant | BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 Somerville, NJ 08876 |
Contact | John Carsello |
Correspondent | John Carsello BIOSEARCH MEDICAL PRODUCTS, INC. 35 INDUSTRIAL PKWY. P.O. BOX 1700 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 | 1988-08-23 |
Decision Date | 1988-11-08 |