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FDA 510(k) Application Details - K033126
Device Classification Name
Monitor, Penile Tumescence
More FDA Info for this Device
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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More FDA Info for this Product Code
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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