Device Classification Name |
Staple, Implantable
|
510(k) Number |
K131563 |
Device Name |
SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM |
Applicant |
OPUS KSD, INC. |
62 Forest Street |
Suite 300 |
Marlborough,
MA
01752
|
|
Applicant Contact |
ROSINA ROBINSON, RN, MED, RAC |
Correspondent |
APTIV SOLUTIONS |
62 Forest Street |
Suite 300 |
Marlborough,
MA
01752
|
|
Correspondent Contact |
ROSINA ROBINSON, RN, MED, RAC |
Regulation Number | 878.4750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/30/2013 |
Decision Date | 04/09/2014 |
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
|
|
|