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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 K973195
Device Name TOTAL PERFORMANCE SYSTEM SHAVER
Applicant
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact ERIC FINLEY
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact ERIC FINLEY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/26/1997
Decision Date 10/24/1997
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
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