Device Classification Name |
Otoscope
|
510(k) Number |
K952578 |
Device Name |
WELCH ALLY OTOSCOPE |
Applicant |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
CRAIG MULLIN |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
CRAIG MULLIN |
Regulation Number | 874.4770
|
Classification Product Code |
|
Date Received | 06/05/1995 |
Decision Date | 07/10/1995 |
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
|
|
|