Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K220219 |
Device Name |
PERMALOOP Suture, PERMATAPE Suture |
Applicant |
Medos International SARL |
Chemin-Blanc 38, Case Postale |
Le Locle,
CH
CH 2400
|
|
Applicant Contact |
Ashley Aromando (Goncalo) |
Correspondent |
DePuy Synthes Mitek Sports Medicine |
325 Paramount Drive |
Raynham,
MA
02767
|
|
Correspondent Contact |
Ashley Aromando (Goncalo) |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 01/26/2022 |
Decision Date | 04/26/2022 |
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
|