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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NameFETOSCOPY INSTRUMENT SET
Classification Nameamnioscope, transabdominal (fetoscope) (and accessories)
Generic Nameamnioscope, transabdominal (fetoscope) (and accessories)
Regulation Number884.1600
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand ave.
el segundo, CA 90245
HDE NumberH040005
Date Received06/30/2004
Decision Date03/31/2006
Product Code
HFA[ Registered Establishments with HFA ]
Docket Number 06M0163
Notice Date 04/21/2006
Advisory Committee Obstetrics/Gynecology
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
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