The following data is part of a premarket notification filed by Medicorp, Inc. with the FDA for Ultramax.
Device ID | K832705 |
510k Number | K832705 |
Device Name: | ULTRAMAX |
Classification | Dialyzer Reprocessing System |
Applicant | MEDICORP, INC. 240 WEST 2950 SOUTH Salt Lake City , UT 84115 - |
Contact | Richard K Fife |
Correspondent | Richard K Fife MEDICORP, INC. 240 WEST 2950 SOUTH Salt Lake City , UT 84115 - |
Product Code | LIF |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-12 |
Decision Date | 1984-06-25 |