Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K193085 |
Device Name |
PuraDERM Gel |
Applicant |
3-D Matrix, Inc. |
250 First Ave., Suite 205 |
Needham,
MA
02494
|
|
Applicant Contact |
Lisa Spirio |
Correspondent |
Streamline Regulatory |
3502 Dundee Driveway |
Chevy Chase,
MD
20815
|
|
Correspondent Contact |
Stephen P. Rhodes |
Classification Product Code |
|
Date Received | 11/05/2019 |
Decision Date | 05/11/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|