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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 K962246
Device Name RIGID FIBER OPTIC LAPAROSCOPE
Applicant
Health Care International Assoc.
10551 Wulff Dr.
Villa Park,  CA  92667
Applicant Contact RONALD J EHMSEN
Correspondent
Health Care International Assoc.
10551 Wulff Dr.
Villa Park,  CA  92667
Correspondent Contact RONALD J EHMSEN
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/11/1996
Decision Date 02/07/1997
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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