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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 K895303
Device Name EVER-SHARP BIOPSY FORCEPS
Applicant
SOUTHWEST MEDICAL MFG., INC.
P.O. BOX 71261
MARIETTA,  GA  30007
Applicant Contact MIKE SIBLEY
Correspondent
SOUTHWEST MEDICAL MFG., INC.
P.O. BOX 71261
MARIETTA,  GA  30007
Correspondent Contact MIKE SIBLEY
Regulation Number884.4530
Classification Product Code
HFB  
Date Received08/29/1989
Decision Date 01/16/1990
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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