Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K202950 |
Device Name |
StitchKit COMBO |
Applicant |
Origami Surgical |
79 Haven St. |
Dover,
MA
02030
|
|
Applicant Contact |
John Gillespie |
Correspondent |
Origami Surgical |
79 Haven St. |
Dover,
MA
02030
|
|
Correspondent Contact |
John Gillespie |
Regulation Number | 878.4493
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/30/2020 |
Decision Date | 02/23/2021 |
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
|
|
|