FDA 510(k) Application Details - K003128

Device Classification Name Orthosis, Truncal, For Dysmenorrhea

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510(K) Number K003128
Device Name Orthosis, Truncal, For Dysmenorrhea
Applicant THE JM KOHN CO.
201 SPEAR ST.
SUITE 1600
SAN FRANCISCO, CA 94105-1635 US
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Contact CHARLES L MORIN
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Regulation Number 890.3490

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Classification Product Code NJB
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Date Received 10/06/2000
Decision Date 08/12/2002
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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