510(k) K812441

DI-CROWN by Coburn Optical Ind., Inc. — Product Code HQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1981
Date Received
August 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Spectacle, Non-Custom (Prescription)
Device Class
Class I
Regulation Number
886.5844
Review Panel
OP
Submission Type