Device Classification Name |
Block, Bite
|
510(k) Number |
K960663 |
Device Name |
UNIVERSAL BITE BLOCK |
Applicant |
B & B MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 1503 |
ORANGEVALE,
CA
95662
|
|
Applicant Contact |
JOHN D CALEBAUGH RRT,RCP |
Correspondent |
B & B MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 1503 |
ORANGEVALE,
CA
95662
|
|
Correspondent Contact |
JOHN D CALEBAUGH RRT,RCP |
Regulation Number | 882.5070
|
Classification Product Code |
|
Date Received | 02/16/1996 |
Decision Date | 05/17/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|