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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K932387
Device Name CONCEPTUS VARI-SOFT CATH/PIROUETTE POSIT MANDREL
Applicant
CONCEPTUS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Applicant Contact ALEXIS BALL
Correspondent
CONCEPTUS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Correspondent Contact ALEXIS BALL
Regulation Number884.1720
Classification Product Code
HET  
Date Received05/17/1993
Decision Date 03/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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