Device Classification Name |
set, i.v. fluid transfer
|
510(k) Number |
K983794 |
Device Name |
CHEMO MINI SPIKE PLUS |
Applicant |
B. BRAUN OF AMERICA, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18103
|
|
Applicant Contact |
MARK S ALSBERGE |
Correspondent |
B. BRAUN OF AMERICA, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18103
|
|
Correspondent Contact |
MARK S ALSBERGE |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/27/1998 |
Decision Date | 03/23/1999 |
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
|
|
|