Device Classification Name |
I.V. Start Kit
|
510(k) Number |
K863712 |
Device Name |
I.V. START KIT, STERILE, DISPOSABLES |
Applicant |
BUSSE HOSPITAL DISPOSABLES, INC. |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
PARTHA BASUMALLIK |
Correspondent |
BUSSE HOSPITAL DISPOSABLES, INC. |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
PARTHA BASUMALLIK |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 09/23/1986 |
Decision Date | 10/22/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|