FDA 510(k) Application Details - K033126

Device Classification Name Monitor, Penile Tumescence

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510(K) Number K033126
Device Name Monitor, Penile Tumescence
Applicant BEHAVIORAL TECHNOLOGY, INC.
24 M ST., #1
SALT LAKE CITY, UT 84103 US
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Contact SUSAN E OLSEN
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Regulation Number 000.0000

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Classification Product Code LIL
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Date Received 09/30/2003
Decision Date 10/29/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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