Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K110794 |
Device Name |
AMECATH CVC AND AMECATH PRESSURE CVC SHORT TERM SINGLE AND MULTI-LUMEN CATHERIZATION KITS |
Applicant |
AMECO MEDICAL INDUSTRIES |
79 BROOKLINE ROAD |
MASON,
NH
03048
|
|
Applicant Contact |
Ray Kelly |
Correspondent |
AMECO MEDICAL INDUSTRIES |
79 BROOKLINE ROAD |
MASON,
NH
03048
|
|
Correspondent Contact |
Ray Kelly |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/22/2011 |
Decision Date | 12/21/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|