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FDA 510(k) Application Details - K050295
Device Classification Name
Needle, Acupuncture, Single Use
More FDA Info for this Device
510(K) Number
K050295
Device Name
Needle, Acupuncture, Single Use
Applicant
HELIO MEDICAL SUPPLIES, INC.
606 CHARCOT AVE.
SAN JOSE, CA 95131 US
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Contact
ERIC CHENG
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
02/07/2005
Decision Date
03/25/2005
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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