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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 K913559
Device Name OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
Applicant
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Applicant Contact BRYSON, JR.
Correspondent
Osteo AG
208 Wilson Bridge Rd.
Greenwood,  SC  29646
Correspondent Contact BRYSON, JR.
Regulation Number878.4820
Classification Product Code
HSZ  
Date Received08/09/1991
Decision Date 11/07/1991
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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