The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Automatic Peritoneal Dialysis Cycler.
Device ID | K833065 |
510k Number | K833065 |
Device Name: | AUTOMATIC PERITONEAL DIALYSIS CYCLER |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-08 |
Decision Date | 1983-11-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50085412030550 | K833065 | 000 |
50085412007675 | K833065 | 000 |