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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 K991960
Device Name SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH
Applicant
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Applicant Contact N. MANI PRAKASH
Correspondent
Stryker Endoscopy
2590 Walsh Ave.
Santa Clara,  CA  95051
Correspondent Contact N. MANI PRAKASH
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/10/1999
Decision Date 08/13/1999
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
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