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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K060198
Device Name MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW
Applicant
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Applicant Contact ELIZABETH PAUL
Correspondent
Linvatec Corp.
11311 Concept Blvd.
Largo,  FL  33773 -4908
Correspondent Contact ELIZABETH PAUL
Regulation Number888.1100
Classification Product Code
HRX  
Date Received01/26/2006
Decision Date 05/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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