FDA 510(k) Application Details - K983239

Device Classification Name Subsystem, Water Purification

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510(K) Number K983239
Device Name Subsystem, Water Purification
Applicant RASCO
1635-2 WOODSIDE DR.
WOODBRIDGE, VA 22191 US
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Contact VINCENT J CICCONE
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Regulation Number 876.5665

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Classification Product Code FIP
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Date Received 09/15/1998
Decision Date 11/18/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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