Device Classification Name |
Suture, Absorbable, Synthetic, Polyglycolic Acid
|
510(k) Number |
K143584 |
Device Name |
PGA RESORBA, PGA RESOQUICK, GLYCOLON |
Applicant |
RESORBA MEDICAL GMBH |
AM FLACHMOOOR 16 |
NUREMBERG,
DE
90475
|
|
Applicant Contact |
KARL JOSEF BECK |
Correspondent |
RESORBA MEDICAL GMBH |
AM FLACHMOOOR 16 |
NUREMBERG,
DE
90475
|
|
Correspondent Contact |
KARL JOSEF BECK |
Regulation Number | 878.4493
|
Classification Product Code |
|
Date Received | 12/18/2014 |
Decision Date | 11/02/2015 |
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
|
|
|