Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
510(k) Number |
K963949 |
Device Name |
KSEA UNIMAT PLUS |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
KEVIN A KENNAN |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
KEVIN A KENNAN |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 10/02/1996 |
Decision Date | 12/19/1996 |
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
|
|
|