Device Classification Name |
absorbable synthetic wound dressing
|
510(k) Number |
K170300 |
Device Name |
Restrata Wound Matrix |
Applicant |
Acera Surgical, Inc. |
10880 Baur Blvd. |
St. Louis,
MO
63132
|
|
Applicant Contact |
Tamas Kovacs |
Correspondent |
Secure BioMed Evaluations |
7828 Hickory Flat Highway Suite 120 |
Woodstock,
GA
30188
|
|
Correspondent Contact |
Linda Braddon |
Classification Product Code |
|
Date Received | 01/31/2017 |
Decision Date | 04/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|