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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 K851110
Device Name GAYLOR-THOMS UTERINE BIOPSY FORCEPS 1810-144 PCS.
Applicant
THE HUXLEY INSTRUMENT CORP.
215 MAIN ST.
PENN YAN,  NY  14527
Applicant Contact REBECCA J SHAHZADA
Correspondent
THE HUXLEY INSTRUMENT CORP.
215 MAIN ST.
PENN YAN,  NY  14527
Correspondent Contact REBECCA J SHAHZADA
Regulation Number884.4530
Classification Product Code
HFB  
Date Received03/19/1985
Decision Date 04/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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