FDA 510(k) Application Details - K960262

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K960262
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant COOK UROLOGICAL, INC.
1100 WEST MORGAN ST.
P.O. BOX 227
SPENCER, IN 47460 US
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Contact TAMMY BACON
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 01/18/1996
Decision Date 04/15/1996
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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