The following data is part of a premarket notification filed by Anatech, Ltd. with the FDA for Pro-par Clearant.
Device ID | K842861 |
510k Number | K842861 |
Device Name: | PRO-PAR CLEARANT |
Classification | Agent, Clearing |
Applicant | ANATECH, LTD. 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 | 1984-07-23 |
Decision Date | 1984-08-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRO-PAR CLEARANT 73646656 not registered Dead/Abandoned |
ANATECH, LTD. 1987-02-26 |