Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K973620 |
Device Name |
VACUETTE MULTI-SAMPLE NEEDLE |
Applicant |
GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A |
BEL AIR,
MD
21014
|
|
Applicant Contact |
DOUGLAS L HARRIS |
Correspondent |
GREINER MEDITECH, INC. |
260 GATEWAY DRIVE, SUITE 17A |
BEL AIR,
MD
21014
|
|
Correspondent Contact |
DOUGLAS L HARRIS |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 09/23/1997 |
Decision Date | 12/17/1997 |
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
|
|
|