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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K850502
Device Name H/G CUP POSITIONER (1520) LEFT-500PCS RIGHT 500PCS
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
Date Received02/08/1985
Decision Date 03/01/1985
Decision Substantially Equivalent (SESE)
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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