Device Classification Name |
Mask, Gas, Anesthetic
|
510(k) Number |
K950771 |
Device Name |
DISPOSABLE ADHESIVE FACE MASK |
Applicant |
ADVANCED WARMING SYSTEMS, INC. |
3414 22ND ST. |
LUBBOCK,
TX
79410
|
|
Applicant Contact |
RANDY HICKLE |
Correspondent |
ADVANCED WARMING SYSTEMS, INC. |
3414 22ND ST. |
LUBBOCK,
TX
79410
|
|
Correspondent Contact |
RANDY HICKLE |
Regulation Number | 868.5550
|
Classification Product Code |
|
Date Received | 02/21/1994 |
Decision Date | 03/10/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|