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FDA 510(k) Application Details - K983798
Device Classification Name
Needle, Acupuncture, Single Use
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510(K) Number
K983798
Device Name
Needle, Acupuncture, Single Use
Applicant
SEDATELEC
200 GREGORY LANE, SUITE C-100
PLEASANT HILL, CA 94523-3389 US
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Contact
DAVID W SCHLERF
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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
10/28/1998
Decision Date
08/27/1999
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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