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FDA 510(k) Application Details - K983246
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K983246
Device Name
Device, External Penile Rigidity
Applicant
POS-T-VAC, INC.
1701 NORTH 14TH AVE.
P.O. BOX 1436
DODGE CITY, KS 67801 US
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Contact
ED STEWART JR
Other 510(k) Applications for this Contact
Regulation Number
876.5020
More FDA Info for this Regulation Number
Classification Product Code
LKY
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More FDA Info for this Product Code
Date Received
09/16/1998
Decision Date
11/02/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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