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 |