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510(k) K033728

TRANSVAGINAL ENDOSCOPY SET by KARL STORZ Endoscopy-America, Inc. — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2004
Date Received
November 28, 2003
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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  • K111014 — LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES (July 13, 2012)
  • K110819 — SINGHMED ROOLIP MANIPULATOR (October 5, 2011)
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