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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K033135
Device Name STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Applicant Contact MIKE HILLDOERFER
Correspondent
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Correspondent Contact MIKE HILLDOERFER
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Codes
GCJ   HRX  
Date Received09/30/2003
Decision Date 08/09/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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