Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K040439 |
Device Name |
MDI TRIGGER GUARD |
Applicant |
NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP. |
30 NORTHPORT ROAD |
SOUND BEACH,
NY
11789 -1734
|
|
Applicant Contact |
RICHARD LANZILLOTTO |
Correspondent |
NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP. |
30 NORTHPORT ROAD |
SOUND BEACH,
NY
11789 -1734
|
|
Correspondent Contact |
RICHARD LANZILLOTTO |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/19/2004 |
Decision Date | 07/08/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|