FDA 510(k) Application Details - K980779

Device Classification Name Bandage, Liquid

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510(K) Number K980779
Device Name Bandage, Liquid
Applicant DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO M1S 3S4 CA
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Contact SHARMINI ATHERAY, M.SC
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Regulation Number 880.5090

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Classification Product Code KMF
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Date Received 03/02/1998
Decision Date 06/26/1998
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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