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FDA 510(k) Application Details - K051742
Device Classification Name
Needle, Assisted Reproduction
More FDA Info for this Device
510(K) Number
K051742
Device Name
Needle, Assisted Reproduction
Applicant
INNTEC, INC.
800 LEVANGER LANE
STOUGHTON, WI 53589 US
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Contact
Gary Syring
Other 510(k) Applications for this Contact
Regulation Number
884.6100
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Classification Product Code
MQE
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More FDA Info for this Product Code
Date Received
06/28/2005
Decision Date
10/07/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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