FDA 510(k) Application Details - K033177

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K033177
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant GUNTER BISSINGER MEDIZINTECHNIK GMBH
AMSTEL 320-I
AMSTERDAM 1017 AP NL
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Contact DAGMAR MASER
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 10/01/2003
Decision Date 03/11/2004
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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