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510(k) K853668

ORC ORACLE by Optical Radiation Corp. — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1985
Date Received
September 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

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