Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K980492 |
Device Name |
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) |
Applicant |
CIRCON ACMI |
300 STILLWATER AVE. |
P.O. BOX 1971 |
STAMFORD,
CT
06904 -1971
|
|
Applicant Contact |
RONALD J EHMSEN |
Correspondent |
CIRCON ACMI |
300 STILLWATER AVE. |
P.O. BOX 1971 |
STAMFORD,
CT
06904 -1971
|
|
Correspondent Contact |
RONALD J EHMSEN |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 02/09/1998 |
Decision Date | 11/17/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|