FDA 510(k) Application Details - K962416

Device Classification Name Alarm, Conditioned Response Enuresis

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510(K) Number K962416
Device Name Alarm, Conditioned Response Enuresis
Applicant BIO-SYSTEMS RESEARCH
2057 SUMMIT DR.
LAKE OSWEGO, OR 97034 US
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Contact ARTHUR J SAFFIR
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Regulation Number 876.2040

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Classification Product Code KPN
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Date Received 04/30/1996
Decision Date 07/22/1996
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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