Device Classification Name |
Light, Examination, Medical, Battery Powered
|
510(k) Number |
K760972 |
Device Name |
TYCOS DIAGNOSTIC PENLIGHT |
Applicant |
TAYLOR INSTRUMENT ANALYTICS CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TAYLOR INSTRUMENT ANALYTICS CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.6350 |
Classification Product Code |
|
Date Received | 11/04/1976 |
Decision Date | 01/26/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|