Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K151200 |
Device Name |
STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device |
Applicant |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Applicant Contact |
DONNA MARSHALL |
Correspondent |
ETHICON, INC. |
ROUTE 22 WEST |
P.O. BOX 151 |
SOMERVILLE,
NJ
08876 -0151
|
|
Correspondent Contact |
DONNA MARSHALL |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 05/05/2015 |
Decision Date | 08/13/2015 |
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 |
Yes
|
Recalls |
CDRH Recalls
|
|
|