510(k) K811799

CLEAR-MOUNT by Richard-Allan Medical Ind., Inc. — Product Code LEB

K811799 is an FDA 510(k) premarket notification submitted by Richard-Allan Medical Ind., Inc. for the device "CLEAR-MOUNT". The FDA issued a decision of Substantially Equivalent on July 31, 1981. The device falls under product code LEB (Mounting Media), a Class I device regulated under 21 CFR 864.4010. Richard-Allan Medical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1981
Date Received
June 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mounting Media
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type