Device Classification Name |
mask, oxygen
|
510(k) Number |
K905288 |
Device Name |
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES |
Applicant |
MED-TEK INNOVATIONS, INC. |
6685 N. SIDNEY PL. |
GLENDALE,
WI
53209
|
|
Applicant Contact |
ALAN E WHITMARSH |
Correspondent |
MED-TEK INNOVATIONS, INC. |
6685 N. SIDNEY PL. |
GLENDALE,
WI
53209
|
|
Correspondent Contact |
ALAN E WHITMARSH |
Regulation Number | 868.5580
|
Classification Product Code |
|
Date Received | 11/26/1990 |
Decision Date | 04/09/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|