Device Classification Name |
Clip, Implantable
|
510(k) Number |
K052018 |
Device Name |
MILTEX LIGATING CLIP |
Applicant |
MILTEX, INC. |
589 DAVIES DRIVE |
YORK,
PA
17402
|
|
Applicant Contact |
CHARLES WEAVER |
Correspondent |
MILTEX, INC. |
589 DAVIES DRIVE |
YORK,
PA
17402
|
|
Correspondent Contact |
CHARLES WEAVER |
Regulation Number | 878.4300
|
Classification Product Code |
|
Date Received | 07/26/2005 |
Decision Date | 11/04/2005 |
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
|
|
|