Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K934167 |
Device Name |
IPI DUAL LUMEN PORT |
Applicant |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
125-B CREMONA DR. |
GOLETA,
CA
93117
|
|
Applicant Contact |
TOM HOLDYCH |
Correspondent |
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. |
125-B CREMONA DR. |
GOLETA,
CA
93117
|
|
Correspondent Contact |
TOM HOLDYCH |
Regulation Number | 880.5965 |
Classification Product Code |
|
Date Received | 08/27/1993 |
Decision Date | 07/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|