The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Skin Markers.
Device ID | K821063 |
510k Number | K821063 |
Device Name: | SKIN MARKERS |
Classification | Marker, Skin |
Applicant | DEVON INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FZZ |
CFR Regulation Number | 878.4660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-07 |
Decision Date | 1982-06-25 |