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510(k) K110819

SINGHMED ROOLIP MANIPULATOR by J.Singh Instruments — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2011
Date Received
March 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culdoscope (And Accessories)
Device Class
Class II
Regulation Number
884.1640
Review Panel
OB
Submission Type

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