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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K952032
Device Name IMAGYN HYSTEROSCOPE SHEATHS
Applicant
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Applicant Contact DEBRA A RINDERER
Correspondent
IMAGYN MEDICAL, INC.
27651 LA PAZ RD.
LAGUNA NIGUEL,  CA  92656 -3917
Correspondent Contact DEBRA A RINDERER
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/01/1995
Decision Date 10/31/1995
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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