The following data is part of a premarket notification filed by Richard-allan Medical Ind., Inc. with the FDA for Clear-mount.
Device ID | K811799 |
510k Number | K811799 |
Device Name: | CLEAR-MOUNT |
Classification | Mounting Media |
Applicant | RICHARD-ALLAN MEDICAL IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LEB |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-24 |
Decision Date | 1981-07-31 |