Device Classification Name |
block, bite
|
510(k) Number |
K830090 |
Device Name |
DISPOSABLE BITE BLOCK/TONGUE DEPRESSOR |
Applicant |
HUDSON OXYGEN THERAPY SALES CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
HUDSON OXYGEN THERAPY SALES CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 882.5070
|
Classification Product Code |
|
Date Received | 01/11/1983 |
Decision Date | 02/07/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|