The following data is part of a premarket notification filed by Rochal Industries Llc with the FDA for Atteris No-sting Skin Protectant.
Device ID | K160684 |
510k Number | K160684 |
Device Name: | Atteris No-Sting Skin Protectant |
Classification | Bandage, Liquid |
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 | KMF |
CFR Regulation Number | 880.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-11 |
Decision Date | 2016-07-26 |
Summary: | summary |