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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anesthesia Conduction Kit
510(k) Number K051171
Device Name STINGRAY EPIDURAL CATHETER CONNECTOR
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 Number868.5140
Classification Product Code
CAZ  
Date Received05/06/2005
Decision Date 08/26/2005
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
Recalls CDRH Recalls
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