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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Surgical, Gynecological
510(k) Number K944055
Device Name FORCEPS, SURGICAL GYNECOLOGICAL
Applicant
Owens Precision Systems, Inc.
7815 S. 6th St.
Oak Creek,  WI  53154
Applicant Contact LANIS P PFOLSGROF
Correspondent
Owens Precision Systems, Inc.
7815 S. 6th St.
Oak Creek,  WI  53154
Correspondent Contact LANIS P PFOLSGROF
Regulation Number884.4530
Classification Product Code
HCZ  
Date Received08/19/1994
Decision Date 09/20/1994
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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