Device Classification Name |
Dental Barriers And Sleeves
|
510(k) Number |
K151123 |
FOIA Releasable 510(k) |
K151123
|
Device Name |
Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film |
Applicant |
Pac-Dent International, Inc. |
670 Endeavor Circle |
Brea,
CA
92821
|
|
Applicant Contact |
Wenying Zhu |
Correspondent |
Pac-Dent International, Inc. |
670 Endeavor Circle |
Brea,
CA
92821
|
|
Correspondent Contact |
Wenying Zhu |
Regulation Number | 878.4370
|
Classification Product Code |
|
Date Received | 04/28/2015 |
Decision Date | 03/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|