Device Classification Name |
mask, oxygen
|
510(k) Number |
K945482 |
Device Name |
DISPOSABLE, CPAP OXYGEN MASK |
Applicant |
FVTNKS |
67920 KLINGER LAKE RD. |
STURGIS,
MI
49091 -9288
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
FVTNKS |
67920 KLINGER LAKE RD. |
STURGIS,
MI
49091 -9288
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.5580
|
Classification Product Code |
|
Date Received | 11/08/1994 |
Decision Date | 09/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|