LINVATEC 10K IRRIGATION SYSTEM

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

Correspodent Contact laura d krejci
Regulation Number 888.1100
Classification Product Code
HRX  
Subsequent Product Code
GCI  
Date Received 11/13/2003
Decision Date 02/11/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No