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FDA 510(k) Application Details - K093999
Device Classification Name
Stimulator, Muscle, Powered, For Muscle Conditioning
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510(K) Number
K093999
Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant
ARP MANUFACTURING, INC
4655 KIRKWOOD COURT
BOULDER, CO 80301 US
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Contact
LEWIS WARD
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Regulation Number
890.5850
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Classification Product Code
NGX
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More FDA Info for this Product Code
Date Received
12/28/2009
Decision Date
08/10/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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