Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K081904 |
Device Name |
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) |
Applicant |
MEDCOMP |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEAN CALLOW |
Correspondent |
MEDCOMP |
1499 DELP DR. |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEAN CALLOW |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 07/03/2008 |
Decision Date | 09/23/2008 |
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
|
|
|