Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K980768 |
Device Name |
VACUETTE HOLDEX |
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 | 02/27/1998 |
Decision Date | 04/09/1998 |
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
|
Recalls |
CDRH Recalls
|
|
|