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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K031282
Device Name OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
Applicant
LeMaitre Vascular, Inc.
26 Ray Ave.
Burlington,  MA  01803
Applicant Contact BRIAN K KEOGH
Correspondent
LeMaitre Vascular, Inc.
26 Ray Ave.
Burlington,  MA  01803
Correspondent Contact BRIAN K KEOGH
Regulation Number880.5965
Classification Product Code
LJT  
Date Received04/22/2003
Decision Date 08/05/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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