Device Classification Name |
Reliner, Denture, Over The Counter
|
510(k) Number |
K121318 |
Device Name |
PROSOFT |
Applicant |
PERMA LABORATORIES |
120 Wakefield Run Blvd |
Hinckley,
OH
44233
|
|
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 872.3560
|
Classification Product Code |
|
Date Received | 05/02/2012 |
Decision Date | 06/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|