FDA 510(k) Application Details - K000741

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K000741
Device Name Stimulator, Muscle, Powered
Applicant 138 MEDICAL SUPPLIES, INC.
55 NORTHERN BLVD., SUITE 200
GREAT NECK, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/07/2000
Decision Date 10/24/2001
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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