Device Classification Name |
Oral Wound Dressing
|
510(k) Number |
K193336 |
Device Name |
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse |
Applicant |
Synedgen, Inc. |
1420 North Claremont Blvd. Suite 105D |
Claremont,
CA
91711
|
|
Applicant Contact |
Shenda Baker |
Correspondent |
Synedgen, Inc. |
1420 North Claremont Blvd. Suite 105D |
Claremont,
CA
91711
|
|
Correspondent Contact |
Christopher Ryan |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/02/2019 |
Decision Date | 05/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|