Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K955701 |
Device Name |
NIGHTGUARD DIAGNOSTIC APPLIANCE |
Applicant |
CYCURA CORP. |
P.O. BOX 364 |
ROCKLIN,
CA
95677
|
|
Applicant Contact |
KENT ANDERSON |
Correspondent |
CYCURA CORP. |
P.O. BOX 364 |
ROCKLIN,
CA
95677
|
|
Correspondent Contact |
KENT ANDERSON |
Classification Product Code |
|
Date Received | 12/15/1995 |
Decision Date | 03/08/1996 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|