Device Classification Name |
bougie, urological
|
510(k) Number |
K950125 |
Device Name |
KARL STORZ BOUGIES AND DILATORS |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
BETTY M JOHNSON |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
BETTY M JOHNSON |
Regulation Number | 876.5520
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/12/1995 |
Decision Date | 02/07/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|