Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K021775
Device Classification Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
More FDA Info for this Device
510(K) Number
K021775
Device Name
Lithotriptor, Extracorporeal Shock-Wave,Urological
Applicant
HEALTHTRONICS, INC.
1841 WEST OAK PKWY.
MARIETTA, GA 30062 US
Other 510(k) Applications for this Company
Contact
PETER WEIMAN
Other 510(k) Applications for this Contact
Regulation Number
876.5990
More FDA Info for this Regulation Number
Classification Product Code
LNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/29/2002
Decision Date
12/23/2002
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact