Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K003313 |
Device Name |
FILAC FAS TEMP ELECTRONIC THERMOMETER |
Applicant |
THE KENDALL COMPANY |
444 MCDONNELL BLVD. |
HAZELWOOD,
MO
63042
|
|
Applicant Contact |
KELLY J ROWLAND |
Correspondent |
THE KENDALL COMPANY |
444 MCDONNELL BLVD. |
HAZELWOOD,
MO
63042
|
|
Correspondent Contact |
KELLY J ROWLAND |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 10/23/2000 |
Decision Date | 01/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|