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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 K926594
Device Name OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIES
Applicant
Owens Industries, Inc.
7815 S. 6th St.
Oak Creek,  WI  53154
Applicant Contact TERRENCE R SHORE
Correspondent
Owens Industries, Inc.
7815 S. 6th St.
Oak Creek,  WI  53154
Correspondent Contact TERRENCE R SHORE
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/09/1992
Decision Date 06/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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