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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, assisted reproduction
510(k) Number K051742
Device Name OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH
Applicant
INNTEC, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
INNTEC, INC.
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number884.6100
Classification Product Code
MQE  
Date Received06/28/2005
Decision Date 10/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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