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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 K012667
Device Name REPROCESSED ARTHROSCOPIC SHAPERS
Applicant
Surgical Instruments Service and Savings, Inc.
3636 E Columbine Dr.
Phoenix,  AZ  85032
Applicant Contact ROBERT S MCQUATE
Correspondent
Surgical Instruments Service and Savings, Inc.
3636 E Columbine Dr.
Phoenix,  AZ  85032
Correspondent Contact ROBERT S MCQUATE
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/13/2001
Decision Date 06/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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