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FDA 510(k) Application Details - K972964
Device Classification Name
Dilator, Urethral
More FDA Info for this Device
510(K) Number
K972964
Device Name
Dilator, Urethral
Applicant
ATRION MEDICAL PRODUCTS, INC.
1426 CURT FRANCIS RD.
PO BOX 564
ARAB, AL 35016 US
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Contact
DAN CLARK
Other 510(k) Applications for this Contact
Regulation Number
876.5520
More FDA Info for this Regulation Number
Classification Product Code
KOE
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More FDA Info for this Product Code
Date Received
08/11/1997
Decision Date
10/10/1997
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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