The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Gamma Steril. Capillary Flow Dialy-g15.
Device ID | K832663 |
510k Number | K832663 |
Device Name: | GAMMA STERIL. CAPILLARY FLOW DIALY-G15 |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-08 |
Decision Date | 1983-09-12 |