Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K192527 |
Device Name |
Rochal Antimicrobial Wound Gel |
Applicant |
Rochal Industries, LLC |
12000 Network Blvd, Ste B200 |
San Antonio,
TX
78249
|
|
Applicant Contact |
William J. Coulston |
Correspondent |
Rochal Industries, LLC |
12000 Network Blvd, Ste B200 |
San Antonio,
TX
78249
|
|
Correspondent Contact |
William J. Coulston |
Classification Product Code |
|
Date Received | 09/13/2019 |
Decision Date | 02/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|