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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saw, Powered, And Accessories
510(k) Number K012320
Device Name POWERPRO BATTERY SYSTEM
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact LAURA D SENEFF
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact LAURA D SENEFF
Regulation Number878.4820
Classification Product Code
HAB  
Date Received07/23/2001
Decision Date 10/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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