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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Conduction, Anesthetic
510(k) Number K133316
Device Name SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
Applicant
Epimed International, Inc.
141 Sal Landrio Dr. Crossroads Business Park
Johnstown,  NY  12095
Applicant Contact PRESTON H FRASIER
Correspondent
Epimed International, Inc.
141 Sal Landrio Dr. Crossroads Business Park
Johnstown,  NY  12095
Correspondent Contact PRESTON H FRASIER
Regulation Number868.5120
Classification Product Code
BSO  
Date Received10/28/2013
Decision Date 05/28/2014
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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