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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Instruments, G-U, Manual (And Accessories)
510(k) Number K852725
Device Name BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
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 Number876.4730
Classification Product Code
KOA  
Date Received06/26/1985
Decision Date 07/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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