The following data is part of a premarket notification filed by Venetec, Inc. with the FDA for Statlock-ipidural.
Device ID | K943038 |
510k Number | K943038 |
Device Name: | STATLOCK-IPIDURAL |
Classification | Set, Administration, Intravascular |
Applicant | VENETEC, INC. 1500 QUAIL ST. SUITE 550 Newport Beach, CA 92660 |
Contact | Patricia Amtower |
Correspondent | Patricia Amtower VENETEC, INC. 1500 QUAIL ST. SUITE 550 Newport Beach, CA 92660 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-27 |
Decision Date | 1995-04-10 |