Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K971518 |
Device Name |
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
MARLLENA ALLEN PIERCY |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
MARLLENA ALLEN PIERCY |
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 04/25/1997 |
Decision Date | 07/24/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|