Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K900176 |
Device Name |
ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES |
Applicant |
MACHIDA, INC. |
40 RAMLAND RD. SOUTH |
ORANGEBURG,
NY
10962
|
|
Applicant Contact |
NORMAN ABRAMS |
Correspondent |
MACHIDA, INC. |
40 RAMLAND RD. SOUTH |
ORANGEBURG,
NY
10962
|
|
Correspondent Contact |
NORMAN ABRAMS |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 01/12/1990 |
Decision Date | 04/10/1990 |
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
|
|
|