FDA 510(k) Application Details - K940176

Device Classification Name Cannula, Intrauterine Insemination

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510(K) Number K940176
Device Name Cannula, Intrauterine Insemination
Applicant ACKRAD LABORATORIES
70 JACKSON DR.
CRANFORD, NJ 07016 US
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Contact BERNARD ACKERMAN
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Regulation Number 884.5250

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Classification Product Code MFD
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Date Received 01/11/1994
Decision Date 04/23/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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