The following data is part of a premarket notification filed by Vlv Associates, Inc. with the FDA for Disposable, Ambulatory, Infusion Pumps.
Device ID | K940406 |
510k Number | K940406 |
Device Name: | DISPOSABLE, AMBULATORY, INFUSION PUMPS |
Classification | Pump, Infusion, Elastomeric |
Applicant | VLV ASSOCIATES, INC. 30C RIDGEDALE AVE. East Hanover, NJ 07936 |
Contact | Vincent L Vaillancourt |
Correspondent | Vincent L Vaillancourt VLV ASSOCIATES, INC. 30C RIDGEDALE AVE. East Hanover, NJ 07936 |
Product Code | MEB |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-27 |
Decision Date | 1994-09-02 |