FDA 510(k) Application Details - K850535

Device Classification Name Dressing, Wound, Drug

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510(K) Number K850535
Device Name Dressing, Wound, Drug
Applicant MITRAL MEDICAL LTD.
4070 YOUNGFIELD ST.
WHEAT RIDGE, CO US
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Contact RENA E TODD
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 02/11/1985
Decision Date 06/05/1985
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee -
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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