Device Classification Name |
mask, oxygen, non-rebreathing
|
510(k) Number |
K913164 |
Device Name |
NON REBREATHING MASK |
Applicant |
SPECIALTY PACKAGING PRODUCS, INC. |
19 LEIGH FISHER |
EL PASO,
TX
79906
|
|
Applicant Contact |
EDWARD F VALDEZ |
Correspondent |
SPECIALTY PACKAGING PRODUCS, INC. |
19 LEIGH FISHER |
EL PASO,
TX
79906
|
|
Correspondent Contact |
EDWARD F VALDEZ |
Regulation Number | 868.5570
|
Classification Product Code |
|
Date Received | 07/17/1991 |
Decision Date | 01/15/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|