Device Classification Name |
esophagoscope (flexible or rigid)
|
510(k) Number |
K953849 |
Device Name |
PRISM ELECTROSCOPE |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
BETTY M JOHNSON |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
BETTY M JOHNSON |
Regulation Number | 874.4710
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/16/1995 |
Decision Date | 09/06/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|