Device Classification Name |
Syringe, Piston
|
510(k) Number |
K112475 |
Device Name |
XTRACT SYRINGE KEY SYSTEM |
Applicant |
XTRACT SOLUTIONS |
9495 SW LOCUST SUITE E |
PORTLAND,
OR
97223
|
|
Applicant Contact |
KEITH LOWREY |
Correspondent |
XTRACT SOLUTIONS |
9495 SW LOCUST SUITE E |
PORTLAND,
OR
97223
|
|
Correspondent Contact |
KEITH LOWREY |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 08/29/2011 |
Decision Date | 11/10/2011 |
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
|
|
|