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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 K965055
Device Name IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES
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 Number884.1720
Classification Product Code
HET  
Date Received12/18/1996
Decision Date 03/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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