The following data is part of a premarket notification filed by Puregraft Llc with the FDA for Dermapose Refresh.
Device ID | K193363 |
510k Number | K193363 |
Device Name: | Dermapose Refresh |
Classification | System, Suction, Lipoplasty |
Applicant | Puregraft LLC 420 Stevens Avenue, Suite 220 Solana Beach, CA 92075 |
Contact | Olivia Kim |
Correspondent | Olivia Kim Puregraft LLC 420 Stevens Avenue, Suite 220 Solana Beach, CA 92075 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-04 |
Decision Date | 2020-04-14 |