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FDA 510(k) Application Details - K221903
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
More FDA Info for this Device
510(K) Number
K221903
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
Dornier MedTech America, Inc
1155 Roberts Blvd
Suite 100
Kennesaw, GA 30144 US
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Contact
John Hoffer
Other 510(k) Applications for this Contact
Regulation Number
876.5990
More FDA Info for this Regulation Number
Classification Product Code
LNS
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More FDA Info for this Product Code
Date Received
06/30/2022
Decision Date
02/22/2023
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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