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FDA 510(k) Application Details - K040580
Device Classification Name
Stimulator, Intramuscular, Automatic
More FDA Info for this Device
510(K) Number
K040580
Device Name
Stimulator, Intramuscular, Automatic
Applicant
D.Y. INSTRUMENT, INC.
30 MANNING LANE
CHERRY HILL, NJ 08003 US
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Contact
ANNA D LEE
Other 510(k) Applications for this Contact
Regulation Number
880.5580
More FDA Info for this Regulation Number
Classification Product Code
NRW
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More FDA Info for this Product Code
Date Received
03/04/2004
Decision Date
08/26/2004
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
FDA Source Information for K040580
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