Device Classification Name |
Dilator, Vaginal
|
510(k) Number |
K071754 |
Device Name |
NEO-VAGINA SURGERY SET AND ACCESSORIES |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
CRYSTAL DIZOL |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
CRYSTAL DIZOL |
Regulation Number | 884.3900
|
Classification Product Code |
|
Date Received | 06/28/2007 |
Decision Date | 01/07/2009 |
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
|
|
|