The following data is part of a premarket notification filed by Sonoma Pharmaceuticals with the FDA for Microcyn Antimicrobial Skin And Wound Cleanser.
Device ID | K172622 |
510k Number | K172622 |
Device Name: | Microcyn Antimicrobial Skin And Wound Cleanser |
Classification | Dressing, Wound, Drug |
Applicant | Sonoma Pharmaceuticals 1129 N. McDowell Boulevard Petaluma, CA 94954 |
Contact | Brian W. Martin |
Correspondent | Brian W. Martin Sonoma Pharmaceuticals 1129 N. McDowell Boulevard Petaluma, CA 94954 |
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 | 2017-09-01 |
Decision Date | 2017-11-21 |
Summary: | summary |