FDA 510(k) Application Details - K021272

Device Classification Name Cannula, Manipulator/Injector, Uterine

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510(K) Number K021272
Device Name Cannula, Manipulator/Injector, Uterine
Applicant ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD, NJ 07016 US
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Contact RICHARD HETTENBACH
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Regulation Number 000.0000

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Classification Product Code LKF
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Date Received 04/22/2002
Decision Date 05/21/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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