Device Classification Name |
Mask, Gas, Anesthetic
|
510(k) Number |
K952689 |
Device Name |
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK |
Applicant |
OWENS-BRIGAM MEDICAL CO. |
65 HANES RD. |
NEWLAND,
NC
28657
|
|
Applicant Contact |
BILL BROOKS |
Correspondent |
OWENS-BRIGAM MEDICAL CO. |
65 HANES RD. |
NEWLAND,
NC
28657
|
|
Correspondent Contact |
BILL BROOKS |
Regulation Number | 868.5550
|
Classification Product Code |
|
Date Received | 06/12/1995 |
Decision Date | 07/11/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|