Device Classification Name |
laparoscope, gynecologic (and accessories)
|
510(k) Number |
K962985 |
Device Name |
KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
KEVIN KENNAN |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
KEVIN KENNAN |
Regulation Number | 884.1720
|
Classification Product Code |
|
Date Received | 08/01/1996 |
Decision Date | 12/19/1997 |
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
|
|
|