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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rasp, Surgical, General & Plastic Surgery
510(k) Number K884473
Device Name RUBIN BONE PLANER W/REPLACEABLE BLADE
Applicant
Neo Contemporary Co.
795a Southern Artery
Quincy,  MA  02169
Applicant Contact ERROL B RUBIN
Correspondent
Neo Contemporary Co.
795a Southern Artery
Quincy,  MA  02169
Correspondent Contact ERROL B RUBIN
Regulation Number878.4800
Classification Product Code
GAC  
Date Received10/25/1988
Decision Date 12/09/1988
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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