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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 K113662
Device Name FENESTRATED NERVE BLOCK NEEDLE
Applicant
IMD INC
PO BOX 510
9202 KELLY DRIVE
HUNTSVILLE,  UT  84317
Applicant Contact WALTER ZOHMANN
Correspondent
IMD INC
PO BOX 510
9202 KELLY DRIVE
HUNTSVILLE,  UT  84317
Correspondent Contact WALTER ZOHMANN
Regulation Number868.5140
Classification Product Code
CAZ  
Date Received12/07/2011
Decision Date 04/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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