Device Classification Name |
resectoscope
|
510(k) Number |
K934647 |
Device Name |
KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Applicant Contact |
ROBERT R GIORGINI |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
10111 W. JEFFERSON BLVD. |
CULVER CITY,
CA
90232 -3578
|
|
Correspondent Contact |
ROBERT R GIORGINI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/29/1993 |
Decision Date | 02/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|