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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K052141
Device Name STRYKER STILETTO ELECTROSURGICAL PROBE
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Applicant Contact CRYSTAL ONG
Correspondent
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE,  CA  95138
Correspondent Contact CRYSTAL ONG
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/08/2005
Decision Date 10/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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