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510(k) K033113

UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 by Richard Wolf Medical Instruments Corp. — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2003
Date Received
September 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

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