Device Classification Name |
transilluminator, fiber optic
|
510(k) Number |
K962032 |
Device Name |
KARL STORZ TWIN TRANSILLUMINATOR |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
MARIKA ANDERSON |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
MARIKA ANDERSON |
Regulation Number | 874.4350
|
Classification Product Code |
|
Date Received | 05/24/1996 |
Decision Date | 07/05/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|