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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Bending Or Contouring
510(k) Number K872858
Device Name WILLIAMS VERTEBRAL SPREADER
Applicant
Ace Medical Co.
David W. Schlerf
921 Calle Verde
Martinez,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
Ace Medical Co.
David W. Schlerf
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number888.4540
Classification Product Code
HXP  
Date Received07/21/1987
Decision Date 10/15/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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