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FDA 510(k) Application Details - K972659
Device Classification Name
Needle, Acupuncture, Single Use
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510(K) Number
K972659
Device Name
Needle, Acupuncture, Single Use
Applicant
DONG BANG, U.S.A.
13640 EAST IMPERIAL HWY., #1
SANTA FE SPRINGS, CA 90670 US
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Contact
SUE KIM
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Regulation Number
880.5580
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Classification Product Code
MQX
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More FDA Info for this Product Code
Date Received
07/15/1997
Decision Date
10/17/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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