Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K142350 |
Device Name |
PK J-HOOK |
Applicant |
GYRUS ACMI INC. |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772
|
|
Applicant Contact |
NEIL KELLY |
Correspondent |
GYRUS ACMI INC. |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
NEIL KELLY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 08/22/2014 |
Decision Date | 01/08/2015 |
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
|