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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
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