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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Acupuncture, Single Use
510(k) Number K042063
Device Name PRESS TACK NEEDLE
Applicant
Asia-Med GmbH & Co. Kg. - Werk Suhl
13 Red Fox Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Asia-Med GmbH & Co. Kg. - Werk Suhl
13 Red Fox Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number880.5580
Classification Product Code
MQX  
Date Received08/02/2004
Decision Date 10/14/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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