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FDA 510(k) Application Details - K011242
Device Classification Name
Needle, Acupuncture, Single Use
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510(K) Number
K011242
Device Name
Needle, Acupuncture, Single Use
Applicant
ACUSUPPLY, INC.
3801 NE 207TH ST.
AVENTURA, FL 33180 US
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FERES DAGER
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Regulation Number
880.5580
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Classification Product Code
MQX
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Date Received
04/23/2001
Decision Date
09/11/2001
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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