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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, conduction, anesthetic (w/wo introducer)
510(k) Number K063380
Device Name ECHOSTIM FACET TIP
Applicant
HAVEL'S, INC.
3726 LONSDALE ST.
CINCINNATI,  OH  45227
Applicant Contact PATRICK CARROTHERS
Correspondent
HAVEL'S, INC.
3726 LONSDALE ST.
CINCINNATI,  OH  45227
Correspondent Contact PATRICK CARROTHERS
Regulation Number868.5150
Classification Product Code
BSP  
Date Received11/08/2006
Decision Date 04/25/2007
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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