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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K020926
Device Name EXTENSION SET, MODELS 1911-512
Applicant
Epimed International, Inc.
141 Sal Landrio Dr. Crossroads Business Park
Johnstown,  NY  12095
Applicant Contact CHRISTOPHER B LAKE
Correspondent
Epimed International, Inc.
141 Sal Landrio Dr. Crossroads Business Park
Johnstown,  NY  12095
Correspondent Contact CHRISTOPHER B LAKE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/21/2002
Decision Date 07/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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