Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K810569 |
Device Name |
CONTACT-MICRO COLPOHYSTEROSCOPE |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 884.1690
|
Classification Product Code |
|
Date Received | 03/03/1981 |
Decision Date | 07/16/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|