The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Clear-rite 3.
Device ID | K832451 |
510k Number | K832451 |
Device Name: | CLEAR-RITE 3 |
Classification | Agent, Clearing |
Applicant | RICHARD-ALLAN MEDICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KEM |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-25 |
Decision Date | 1983-08-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEAR-RITE 3 75697848 2332716 Live/Registered |
RICHARD-ALLAN SCIENTIFIC LLC 1999-05-03 |