Device Classification Name |
Dressing, Wound, Drug
|
510(k) Number |
K122595 |
Device Name |
HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM |
Applicant |
DERMAL LIFE LLC |
2995 STEVEN MARTIN DR. |
FAIRFAX,
VA
22031
|
|
Applicant Contact |
DIANE HORWITZ, PH.D., RAC |
Correspondent |
Journey Medical Corporation |
9237 Via De Ventura, Suite 105 |
Scottsdale,
AZ
85258
|
|
Correspondent Contact |
Claude Maraoui |
Classification Product Code |
|
Date Received | 08/24/2012 |
Decision Date | 05/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|