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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K071482
Device Name STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000
Applicant
SYNERGETICS, INC
3845 CORPORATE CENTRE DRIVE
O'FALLON,  MO  63368
Applicant Contact DAN REGAN
Correspondent
SYNERGETICS, INC
3845 CORPORATE CENTRE DRIVE
O'FALLON,  MO  63368
Correspondent Contact DAN REGAN
Regulation Number882.4400
Classification Product Code
GXD  
Subsequent Product Code
GEI  
Date Received05/30/2007
Decision Date 12/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
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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