FDA 510(k) Application Details - K993042

Device Classification Name Sterilant, Medical Devices

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510(K) Number K993042
Device Name Sterilant, Medical Devices
Applicant MEDIVATORS, INC.
7423 AIRPORT FREEWAY
FORT WORTH, TX 76118 US
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Contact NORMAN MINER
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Regulation Number 880.6885

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Classification Product Code MED
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Date Received 09/10/1999
Decision Date 08/17/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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