The following data is part of a premarket notification filed by Dermal Life Llc with the FDA for Hydropermeate Topical Emulsion, Answer2skin Sunburn Relief Cream, Answer2skin First Aid Cream.
| Device ID | K122595 |
| 510k Number | K122595 |
| Device Name: | HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM |
| Classification | Dressing, Wound, Drug |
| Applicant | DERMAL LIFE LLC 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Contact | Diane Horwitz, Ph.d., Rac |
| Correspondent | Diane Horwitz, Ph.d., Rac DERMAL LIFE LLC 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2012-08-24 |
| Decision Date | 2013-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00369489522145 | K122595 | 000 |
| 10369489522067 | K122595 | 000 |