Device Classification Name |
mask, surgical
|
510(k) Number |
K041047 |
Device Name |
ULTRADENT CARBON MASK - UPI #342 |
Applicant |
MEDSPRING GROUP, INCORPORATED |
533 WEST 2600 SOUTH, SUITE 105 |
BOUNTIFUL,
UT
84010
|
|
Applicant Contact |
BRUCE DAVIS |
Correspondent |
MEDSPRING GROUP, INCORPORATED |
533 WEST 2600 SOUTH, SUITE 105 |
BOUNTIFUL,
UT
84010
|
|
Correspondent Contact |
BRUCE DAVIS |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 04/22/2004 |
Decision Date | 12/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|