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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 K982375
Device Name STRYKER HIP ARTHOROSCOPY SET
Applicant
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051 -4085
Applicant Contact BALTAZAR ACOUSTA
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051 -4085
Correspondent Contact BALTAZAR ACOUSTA
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/07/1998
Decision Date 10/02/1998
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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