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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name motor, drill, electric
510(k) Number K002523
Device Name ADVANTAGE DRIVE SYSTEM
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Applicant Contact LAURA D SENEFF
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Correspondent Contact LAURA D SENEFF
Regulation Number882.4360
Classification Product Code
HBC  
Subsequent Product Code
GEY  
Date Received08/15/2000
Decision Date 10/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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