Device Classification Name |
Valve, Non-Rebreathing
|
510(k) Number |
K991617 |
Device Name |
FACE-2-FACE CPR PROTECTION SHIELD |
Applicant |
WHITELINE PLASTICS, INC. |
6800 COLUMBUS ROAD |
MISSISSAUGA, ONTARIO,
CA
L5T 2G1
|
|
Applicant Contact |
WALLY SIMPSON |
Correspondent |
WHITELINE PLASTICS, INC. |
6800 COLUMBUS ROAD |
MISSISSAUGA, ONTARIO,
CA
L5T 2G1
|
|
Correspondent Contact |
WALLY SIMPSON |
Regulation Number | 868.5870
|
Classification Product Code |
|
Date Received | 05/10/1999 |
Decision Date | 11/03/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|