Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K143058 |
Device Name |
PuraDerm Gel |
Applicant |
3-D Matrix, Inc. |
200 West St. Ste 14 |
Waltham,
MA
02451
|
|
Applicant Contact |
Lisa Spirio |
Correspondent |
TekTeam, LLC |
2225 E. Bayshore Rd. |
Palo Alto,
CA
94303
|
|
Correspondent Contact |
Denise Gottfried |
Classification Product Code |
|
Date Received | 10/24/2014 |
Decision Date | 02/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|