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FDA 510(k) Application Details - K011808
Device Classification Name
Needle, Acupuncture, Single Use
More FDA Info for this Device
510(K) Number
K011808
Device Name
Needle, Acupuncture, Single Use
Applicant
ASIA-MED GMBH AND CO KG
13 RED FOX LN.
LITTLETON, CO 80127 US
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Contact
Kevin Walls
Other 510(k) Applications for this Contact
Regulation Number
880.5580
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Classification Product Code
MQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/11/2001
Decision Date
07/10/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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