Device Classification Name |
mouthpiece, breathing
|
510(k) Number |
K853266 |
Device Name |
PLASTIC MOUTH BARRIER HSV-I |
Applicant |
WESTMARK ENTERPRISES, INC. |
8710 TRUMBULL AVE. |
SKOKIE,
IL
60076
|
|
Applicant Contact |
MARK D WESTFALL |
Correspondent |
WESTMARK ENTERPRISES, INC. |
8710 TRUMBULL AVE. |
SKOKIE,
IL
60076
|
|
Correspondent Contact |
MARK D WESTFALL |
Regulation Number | 868.5620
|
Classification Product Code |
|
Date Received | 08/05/1985 |
Decision Date | 10/29/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|