Device Classification Name |
Laparoscope, General & Plastic Surgery
|
510(k) Number |
K934937 |
Device Name |
KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/12/1993 |
Decision Date | 03/23/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|