Device Classification Name |
Tube, Tracheal (W/Wo Connector)
|
510(k) Number |
K924997 |
Device Name |
EDD |
Applicant |
ARC MEDICAL, INC. |
735 PARK NORTH BLVD. |
BLDG 126 |
CLARKSTON,
GA
30021
|
|
Applicant Contact |
HAL NORRIS |
Correspondent |
ARC MEDICAL, INC. |
735 PARK NORTH BLVD. |
BLDG 126 |
CLARKSTON,
GA
30021
|
|
Correspondent Contact |
HAL NORRIS |
Regulation Number | 868.5730
|
Classification Product Code |
|
Date Received | 10/02/1992 |
Decision Date | 03/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|