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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hysteroscope (and accessories)
510(k) Number K040390
Device Name STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Applicant Contact CHRISTOPHER L COOK
Correspondent
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Correspondent Contact CHRISTOPHER L COOK
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Codes
FAJ   FAS   KQT  
Date Received02/17/2004
Decision Date 05/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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