FDA 510(k) Application Details - K961922

Device Classification Name Laparoscope, Gynecologic (And Accessories)

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510(K) Number K961922
Device Name Laparoscope, Gynecologic (And Accessories)
Applicant RANFAC CORP.
30 DOHERTY AVE., P.O. BOX 635
AVON INDUSTRIAL PARK
AVON, MA 02322 US
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Contact RAYMOND D LANGLEY
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Regulation Number 884.1720

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Classification Product Code HET
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Date Received 05/17/1996
Decision Date 08/09/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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