FDA 510(k) Application Details - K100580

Device Classification Name Dressing, Wound, Drug

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510(K) Number K100580
Device Name Dressing, Wound, Drug
Applicant EXCITON TECHNOLOGIES INC.
SUITE 4232, 10230 JASPER AVE
EDMONTON, ALBERTA T5J 4P6 CA
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Contact JOHN SIMON
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 03/02/2010
Decision Date 10/12/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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