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FDA 510(k) Application Details - K971768
Device Classification Name
Device, External Penile Rigidity
More FDA Info for this Device
510(K) Number
K971768
Device Name
Device, External Penile Rigidity
Applicant
WALLING MEDICAL EQUIPMENT CO.
3000 CANDIDE LN.
MCKINNEY, TX 75070 US
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Contact
ALLAN WALLING
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Regulation Number
876.5020
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Classification Product Code
LKY
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More FDA Info for this Product Code
Date Received
05/13/1997
Decision Date
09/29/1997
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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