FDA 510(k) Application Details - K990178

Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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510(K) Number K990178
Device Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant NORTRADE MEDICAL, INC.
9382 SOUTH 670 WEST
SANDY, UT 84070 US
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Contact JAY W TAYLOR
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Regulation Number 000.0000

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Classification Product Code MGQ
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Date Received 01/20/1999
Decision Date 08/13/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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