Device Classification Name |
Lithotriptor, Electro-Hydraulic
|
510(k) Number |
K883189 |
Device Name |
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Applicant Contact |
ROBERT GIORGINI |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Correspondent Contact |
ROBERT GIORGINI |
Regulation Number | 876.4480
|
Classification Product Code |
|
Date Received | 07/28/1988 |
Decision Date | 02/13/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|