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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Gynecological
510(k) Number K924224
Device Name OWENS BIOPSY FORCEPS
Applicant
Owens Precision Systems, Inc.
7815 S. 6th St.
Oak Creek,  WI  53154
Applicant Contact LANIS PFOLSGROF
Correspondent
Owens Precision Systems, Inc.
7815 S. 6th St.
Oak Creek,  WI  53154
Correspondent Contact LANIS PFOLSGROF
Regulation Number884.4530
Classification Product Code
HFB  
Date Received08/21/1992
Decision Date 02/04/1994
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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