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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 K063489
Device Name STRYKER INTRADISCAL RF GENERATOR
Applicant
Synergetics, Inc.
3600 Horizon Dr.
Valley Forge,  PA  19406
Applicant Contact DAN REGAN
Correspondent
Synergetics, Inc.
3600 Horizon Dr.
Valley Forge,  PA  19406
Correspondent Contact DAN REGAN
Regulation Number882.4400
Classification Product Code
GXD  
Date Received11/17/2006
Decision Date 05/23/2007
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
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