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FDA 510(k) Application Details - K974122
Device Classification Name
Needle, Acupuncture, Single Use
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510(K) Number
K974122
Device Name
Needle, Acupuncture, Single Use
Applicant
SCIENTIFIC HEALTH CARE
1491 BAKER STREET, SUITE 1
COSTA MESA, CA 92626 US
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Contact
HENRY WOO
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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
10/31/1997
Decision Date
01/22/1998
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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