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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 K032601
Device Name STRYKER INTERVENTIONAL PAIN RF GENERATOR
Applicant
VALLEY FORGE SCIENTIFIC CORP.
136 GREEN TREE RD.
OAKS,  PA  19456
Applicant Contact JERRY MALIS
Correspondent
VALLEY FORGE SCIENTIFIC CORP.
136 GREEN TREE RD.
OAKS,  PA  19456
Correspondent Contact JERRY MALIS
Regulation Number882.4400
Classification Product Code
GXD  
Date Received08/25/2003
Decision Date 04/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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