Device Classification Name |
i.v. start kit
|
510(k) Number |
K925018 |
Device Name |
IV PREP KIT W/O DRESSING (NON-STERILE) |
Applicant |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Applicant Contact |
FELIX B SANTOS |
Correspondent |
CUSTOMED, INC. |
CALLE IGUALDAD #7 |
FAJARDO,
PR
00738
|
|
Correspondent Contact |
FELIX B SANTOS |
Regulation Number | 880.5200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/24/1992 |
Decision Date | 08/27/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|