Device Classification Name |
esophagoscope (flexible or rigid)
|
510(k) Number |
K051972 |
Device Name |
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
YVONNE FERNANDEZ |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
YVONNE FERNANDEZ |
Regulation Number | 874.4710
|
Classification Product Code |
|
Date Received | 07/21/2005 |
Decision Date | 08/15/2005 |
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
|
|
|