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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 K041980
Device Name MSI S-500L RF GENERATOR
Applicant
Medsphere International, Inc.
48511 Warm Springs Blvd.
Suite 212
Fremont,  CA  94539
Applicant Contact ERIC KAO
Correspondent
Medsphere International, Inc.
48511 Warm Springs Blvd.
Suite 212
Fremont,  CA  94539
Correspondent Contact ERIC KAO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received07/23/2004
Decision Date 08/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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