The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Pediatric Exten. Set For Second-drug.
Device ID | K830198 |
510k Number | K830198 |
Device Name: | PEDIATRIC EXTEN. SET FOR SECOND-DRUG |
Classification | Stopcock, I.v. Set |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-20 |
Decision Date | 1983-02-07 |