Device Classification Name |
Otoscope
|
510(k) Number |
K943721 |
Device Name |
OTOVIEW TELESCOPIC OTOSCOPES |
Applicant |
SMITH & NEPHEW, INC. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Applicant Contact |
DEBORAH A ARTHUR |
Correspondent |
SMITH & NEPHEW, INC. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
DEBORAH A ARTHUR |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 08/01/1994 |
Decision Date | 11/18/1994 |
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
|
|
|