FDA 510(k) Application Details - K850538

Device Classification Name Alarm, Conditioned Response Enuresis

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510(K) Number K850538
Device Name Alarm, Conditioned Response Enuresis
Applicant METATECH CORP.
203 WESTBROOK DR.
AUSTIN, TX US
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Contact WIDNER
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Regulation Number 876.2040

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Classification Product Code KPN
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Date Received 02/11/1985
Decision Date 04/03/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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