Device Classification Name |
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
|
510(k) Number |
K191317 |
Device Name |
StitchKit |
Applicant |
Origami Surgical |
42 Main St. Suite A |
Madison,
NJ
07940
|
|
Applicant Contact |
John Gillespie |
Correspondent |
Origami Surgical |
42 Main St. Suite A |
Madison,
NJ
07940
|
|
Correspondent Contact |
John Gillespie |
Regulation Number | 878.5035
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/15/2019 |
Decision Date | 07/12/2019 |
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
|
|
|