Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K052843 |
Device Name |
BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE |
Applicant |
BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DRIVE |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
MUHAMAD ANSARI |
Correspondent |
BUSSE HOSPITAL DISPOSABLES, INC. |
75 ARKAY DRIVE |
P.O. BOX 11067 |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
MUHAMAD ANSARI |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 10/07/2005 |
Decision Date | 04/17/2006 |
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
|
|
|