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510(k) K031831

TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM by Topcon Medical Systems, Inc. — Product Code HKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
June 13, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type

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