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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K852530
Device Name WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS
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 Number878.4800
Classification Product Code
GAD  
Date Received06/14/1985
Decision Date 06/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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