Device Classification Name |
nasopharyngoscope (flexible or rigid)
|
510(k) Number |
K950809 |
Device Name |
VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES |
Applicant |
VISION-SCIENCES, INC. |
6 STRATHMORE RD. |
NATICK,
MA
01760
|
|
Applicant Contact |
PAMELA PAPINEAU |
Correspondent |
VISION-SCIENCES, INC. |
6 STRATHMORE RD. |
NATICK,
MA
01760
|
|
Correspondent Contact |
PAMELA PAPINEAU |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 02/22/1995 |
Decision Date | 08/05/1996 |
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
|
|
|