FDA 510(k) Application Details - K040580

Device Classification Name Stimulator, Intramuscular, Automatic

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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
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Regulation Number 880.5580

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Classification Product Code NRW
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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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