The following data is part of a premarket notification filed by Dexide, Inc. with the FDA for Dexide Disposable Swab Stick.
Device ID | K791169 |
510k Number | K791169 |
Device Name: | DEXIDE DISPOSABLE SWAB STICK |
Classification | Applicator, Absorbent Tipped, Non-sterile |
Applicant | DEXIDE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KXF |
CFR Regulation Number | 880.6025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-25 |
Decision Date | 1979-07-30 |