The following data is part of a premarket notification filed by Guardian Chemical with the FDA for Monoxychlorosene Warexin.
Device ID | K834455 |
510k Number | K834455 |
Device Name: | MONOXYCHLOROSENE WAREXIN |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | GUARDIAN CHEMICAL 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-19 |
Decision Date | 1984-07-31 |