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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 K943810
Device Name IMAGYN MICROLAP INTRODUCER
Applicant
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Applicant Contact ROBERT J CHIN
Correspondent
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Correspondent Contact ROBERT J CHIN
Regulation Number884.1720
Classification Product Code
HET  
Date Received08/05/1994
Decision Date 01/26/1995
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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