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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 K043467
Device Name FLEXIBLE SPINAL NEEDLE
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
BSP  
Date Received12/15/2004
Decision Date 03/31/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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