Device Classification Name |
Staple, Implantable
|
510(k) Number |
K132472 |
Device Name |
JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD |
Applicant |
JUSTRIGHT SURGICAL, LLC |
128 Blye HIll Landing |
Newbury,
NH
03255
|
|
Applicant Contact |
MICHELE LUCEY |
Correspondent |
JUSTRIGHT SURGICAL, LLC |
128 Blye HIll Landing |
Newbury,
NH
03255
|
|
Correspondent Contact |
MICHELE LUCEY |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/07/2013 |
Decision Date | 02/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|