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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Spinal, Short Term
510(k) Number K051860
Device Name FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
Applicant
Epimed International, Inc.
141 Sal Landrio Dr. Crossroads Business Park
Johnstown,  NY  12095
Applicant Contact CHRISTOPHER LAKE
Correspondent
Epimed International, Inc.
141 Sal Landrio Dr. Crossroads Business Park
Johnstown,  NY  12095
Correspondent Contact CHRISTOPHER LAKE
Regulation Number868.5150
Classification Product Code
MIA  
Date Received07/08/2005
Decision Date 08/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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