FDA 510(k) Application Details - K962246

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K962246
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant HEALTH CARE INTERNATIONAL ASSOC.
10551 WULFF DR.
VILLA PARK, CA 92667 US
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Contact RONALD J EHMSEN
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 06/11/1996
Decision Date 02/07/1997
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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