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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 K033573
Device Name LINVATEC 10K IRRIGATION SYSTEM
Applicant
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Applicant Contact LAURA D KREJCI
Correspondent
LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO,  FL  33773 -4908
Correspondent Contact LAURA D KREJCI
Regulation Number888.1100
Classification Product Code
HRX  
Subsequent Product Code
GCJ  
Date Received11/13/2003
Decision Date 02/11/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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