The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Solution Admin. Set 2c9096 W/10 Pvc.
Device ID | K832284 |
510k Number | K832284 |
Device Name: | SOLUTION ADMIN. SET 2C9096 W/10 PVC |
Classification | Set, Administration, Intravascular |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-13 |
Decision Date | 1983-12-29 |