Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K921393 |
Device Name |
IMAGICA MICRO-ENDOSCOPE |
Applicant |
FIBEROPTIC MEDICAL PRODUCTS, INC. |
4000 BELL ATLANTIC TOWER |
1717 ARCH STREET |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JOHN REISS |
Correspondent |
FIBEROPTIC MEDICAL PRODUCTS, INC. |
4000 BELL ATLANTIC TOWER |
1717 ARCH STREET |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JOHN REISS |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 03/23/1992 |
Decision Date | 08/20/1992 |
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
|
|
|