FDA 510(k) Application Details - K981680

Device Classification Name Subsystem, Water Purification

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510(K) Number K981680
Device Name Subsystem, Water Purification
Applicant DAYTON WATER SYSTEMS
1288 MCCOOK AVE.
DAYTON, OH 45404 US
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Contact CINDY HELTON
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Regulation Number 876.5665

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Classification Product Code FIP
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Date Received 05/13/1998
Decision Date 12/31/1998
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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