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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
510(k) Number K930784
Device Name THE DE SOUTTER M193 REAMER
Applicant
De Soutter Medical, Ltd.
Unit 1 Kings Park
Primrose Hill
Kings Langley Herts,  GB WD4 8ST
Applicant Contact BERNARD GRATWICKE
Correspondent
De Soutter Medical, Ltd.
Unit 1 Kings Park
Primrose Hill
Kings Langley Herts,  GB WD4 8ST
Correspondent Contact BERNARD GRATWICKE
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received02/16/1993
Decision Date 10/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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