The following data is part of a premarket notification filed by Medicorp, Inc. with the FDA for Ultramax Iii, Dialyzer Reprocessing Device.
Device ID | K860026 |
510k Number | K860026 |
Device Name: | ULTRAMAX III, DIALYZER REPROCESSING DEVICE |
Classification | Dialyzer Reprocessing System |
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 | LIF |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-03 |
Decision Date | 1986-03-14 |