510(k) K851555

OPTHALMIC BAR PRISM by Roseburg SA — Product Code HKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1985
Date Received
April 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prism, Bar, Ophthalmic
Device Class
Class I
Regulation Number
886.1650
Review Panel
OP
Submission Type