Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K895245 |
Device Name |
FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE |
Applicant |
OPTIMED TECHNOLOGIES, INC. |
17991 FITCH |
IRVINE,
CA
92714
|
|
Applicant Contact |
EHMSEN, SCD |
Correspondent |
OPTIMED TECHNOLOGIES, INC. |
17991 FITCH |
IRVINE,
CA
92714
|
|
Correspondent Contact |
EHMSEN, SCD |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 08/21/1989 |
Decision Date | 11/17/1989 |
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
|
|
|