FDA 510(k) Application Details - K082451

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K082451
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact DESIREE CRISOLO
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 08/25/2008
Decision Date 12/16/2008
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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