The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Dual Flow Needle.
Device ID | K832136 |
510k Number | K832136 |
Device Name: | DUAL FLOW NEEDLE |
Classification | Needle, Fistula |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FIE |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-01 |
Decision Date | 1983-10-14 |