Device Classification Name |
lithotriptor, electro-hydraulic
|
510(k) Number |
K905553 |
Device Name |
LITHOTRIPTOR SYSTEM MODEL 27080 |
Applicant |
KARL STORZ GMBH & CO. (KST) |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232
|
|
Applicant Contact |
ROBERT R GIORGINI |
Correspondent |
KARL STORZ GMBH & CO. (KST) |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232
|
|
Correspondent Contact |
ROBERT R GIORGINI |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 12/11/1990 |
Decision Date | 06/04/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|