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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K913145
Device Name NUCLEOTOME TISSUE ASPIRATOR/CUTTER
Applicant
Surgical Dynamics, Inc.
1240 S. Loop Rd.
Alameda,  CA  94501
Applicant Contact BRAD HUTTING
Correspondent
Surgical Dynamics, Inc.
1240 S. Loop Rd.
Alameda,  CA  94501
Correspondent Contact BRAD HUTTING
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/16/1991
Decision Date 12/19/1991
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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