Device Classification Name |
syringe, piston
|
510(k) Number |
K043261 |
Device Name |
HARVEST GRAFT DELIVERY SYRINGE |
Applicant |
HARVEST TECHNOLOGIES, CORP. |
40 GRISSOM RD, SUITE 100 |
PLYMOUTH,
MA
02360
|
|
Applicant Contact |
JACK BONASERA |
Correspondent |
HARVEST TECHNOLOGIES, CORP. |
40 GRISSOM RD, SUITE 100 |
PLYMOUTH,
MA
02360
|
|
Correspondent Contact |
JACK BONASERA |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 11/24/2004 |
Decision Date | 03/11/2005 |
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
|
|
|