Device Classification Name |
Mask, Oxygen, Low Concentration, Venturi
|
510(k) Number |
K760518 |
Device Name |
ADAPTER, PER-CEN-TOX-BODY |
Applicant |
LANDMARK PLASTICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
LANDMARK PLASTICS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 868.5600 |
Classification Product Code |
|
Date Received | 08/26/1976 |
Decision Date | 09/03/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|