FDA 510(k) Application Details - K990332

Device Classification Name Gauze, External (With Drug/Biologic/Animal Source Material)

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510(K) Number K990332
Device Name Gauze, External (With Drug/Biologic/Animal Source Material)
Applicant DUMEX MEDICAL SURGICAL PRODUCTS, LTD.
104 SHORTING ROAD
TORONTO, ONTARIO M1S 3S4 CA
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Contact SHARMINI ATHERAY
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Regulation Number 000.0000

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Classification Product Code GER
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Date Received 02/03/1999
Decision Date 04/14/1999
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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