510(k) K930444

MARCO STANDARD KERATOMETERS by Marco Ophthalmic, Inc. — Product Code HJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1993
Date Received
January 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Measuring, Corneal Radius
Device Class
Class I
Regulation Number
886.1450
Review Panel
OP
Submission Type