The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Gamma Sterilized Capillary Flow Dialyz.
Device ID | K823778 |
510k Number | K823778 |
Device Name: | GAMMA STERILIZED CAPILLARY FLOW DIALYZ |
Classification | Accessories, Blood Circuit, Hemodialysis |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KOC |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-15 |
Decision Date | 1983-01-07 |