The following data is part of a premarket notification filed by Medicorp, Inc. with the FDA for Medicorp Dehydracon A Dehydrated Dialysate Concent.
Device ID | K844850 |
510k Number | K844850 |
Device Name: | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT |
Classification | System, Dialysate Delivery, Central Multiple Patient |
Applicant | MEDICORP, INC. 230 WEST 2950 SOUTH Salt Lake City, UT 84115 |
Contact | Richard K Fife |
Correspondent | Richard K Fife MEDICORP, INC. 230 WEST 2950 SOUTH Salt Lake City, UT 84115 |
Product Code | FKQ |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-13 |
Decision Date | 1985-04-02 |