510(k) K791659

MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL by Coburn Optical Ind., Inc. — Product Code HQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1979
Date Received
August 22, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type