Device Classification Name |
Mask, Surgical
|
510(k) Number |
K991559 |
Device Name |
MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD |
Applicant |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Applicant Contact |
LARA N SIMMONS |
Correspondent |
MEDLINE INDUSTRIES, INC. |
ONE MEDLINE PLACE |
MUNDELEIN,
IL
60060
|
|
Correspondent Contact |
LARA N SIMMONS |
Regulation Number | 878.4040
|
Classification Product Code |
|
Date Received | 05/04/1999 |
Decision Date | 08/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|