The following data is part of a premarket notification filed by Virchow Biotech Pvt Ltd with the FDA for Hyaluronic Acid Topical Wound Cream.
Device ID | K172747 |
510k Number | K172747 |
Device Name: | HYALURONIC ACID TOPICAL WOUND CREAM |
Classification | Dressing, Wound, Drug |
Applicant | VIRCHOW BIOTECH PVT LTD 5903 SE Milwaukie Ave Portland, OR 97202 |
Contact | Bruce Gibbins |
Correspondent | Bruce Gibbins VIRCHOW BIOTECH PVT LTD 5903 SE Milwaukie Ave Portland, OR 97202 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-12 |
Decision Date | 2018-04-27 |
Summary: | summary |