Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K032417 |
Device Name |
HEPARIN LOCK FLUSH SYRINGE |
Applicant |
AM2 PAT INC. |
9400 RANSDELL RD., SUITE 10 |
RALEIGH,
NC
27603
|
|
Applicant Contact |
DUSHYANT PATEL |
Correspondent |
AM2 PAT INC. |
9400 RANSDELL RD., SUITE 10 |
RALEIGH,
NC
27603
|
|
Correspondent Contact |
DUSHYANT PATEL |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 08/05/2003 |
Decision Date | 12/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|