FDA 510(k) Application Details - K072158

Device Classification Name Subsystem, Water Purification

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510(K) Number K072158
Device Name Subsystem, Water Purification
Applicant STAUBACH BARROR WATER SYSTEMS, INC.
495 ROTTERDAM IND. PARK
SCHENECTADY, NY 12306 US
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Contact JARROD J STAUBACH
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Regulation Number 876.5665

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Classification Product Code FIP
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Date Received 08/03/2007
Decision Date 02/21/2008
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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