The following data is part of a premarket notification filed by Empire Industries, Inc. with the FDA for Enteral Feeding Pump.
Device ID | K852965 |
510k Number | K852965 |
Device Name: | ENTERAL FEEDING PUMP |
Classification | Pump, Infusion |
Applicant | EMPIRE INDUSTRIES, INC. 262 BROADWAY,P.O. BOX 1045 North Attleboro, MA 02761 |
Contact | Roland Ferland |
Correspondent | Roland Ferland EMPIRE INDUSTRIES, INC. 262 BROADWAY,P.O. BOX 1045 North Attleboro, MA 02761 |
Product Code | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-12 |
Decision Date | 1985-08-21 |