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510(k) K051160

MANIPUSEAL by Insitu Systems — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2005
Date Received
May 5, 2005
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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