The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Clear-rite Ii.
| Device ID | K812846 |
| 510k Number | K812846 |
| Device Name: | CLEAR-RITE II |
| 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 | 1981-10-09 |
| Decision Date | 1981-10-29 |