Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K173874 |
Device Name |
StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO |
Applicant |
Origami Surgical LLC |
42 Main St. Suite A |
Madison,
NJ
07945
|
|
Applicant Contact |
John Gillespie |
Correspondent |
Clover Medical LLC |
79 Haven St. |
Dover,
MA
02030
|
|
Correspondent Contact |
John Gillespie |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/21/2017 |
Decision Date | 05/04/2018 |
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
|
|
|