The following data is part of a premarket notification filed by Rochal Industries Llc with the FDA for Atteris Antimicrobial Skin Protectant.
Device ID | K161212 |
510k Number | K161212 |
Device Name: | Atteris Antimicrobial Skin Protectant |
Classification | Dressing, Wound, Drug |
Applicant | ROCHAL INDUSTRIES LLC 12719 CRANES MILL San Antonio, TX 78230 |
Contact | William J. Coulston |
Correspondent | William J. Coulston ROCHAL INDUSTRIES LLC 12719 CRANES MILL San Antonio, TX 78230 |
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 | 2016-04-28 |
Decision Date | 2016-09-30 |
Summary: | summary |