The following data is part of a premarket notification filed by Faulding Medical Device Co. with the FDA for Sterile Ambulatory Reservoir 60ml/100ml.
Device ID | K962159 |
510k Number | K962159 |
Device Name: | STERILE AMBULATORY RESERVOIR 60ML/100ML |
Classification | Accessories, Pump, Infusion |
Applicant | FAULDING MEDICAL DEVICE CO. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
Contact | Bruce Craney |
Correspondent | Bruce Craney FAULDING MEDICAL DEVICE CO. 8777 EAST VIA DE VENTURA, SUITE 225 Scottsdale, AZ 85258 |
Product Code | MRZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-04 |
Decision Date | 1997-07-18 |