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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 K944842
Device Name ARTHROSCOPE
Applicant
5 Star Medical, Inc.
1455 Woodgrove Sq.
San Jose,  CA  95117
Applicant Contact BEVERLY J STEWART
Correspondent
5 Star Medical, Inc.
1455 Woodgrove Sq.
San Jose,  CA  95117
Correspondent Contact BEVERLY J STEWART
Regulation Number888.1100
Classification Product Code
HRX  
Date Received09/30/1994
Decision Date 01/24/1995
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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