The following data is part of a premarket notification filed by Microcopy, Div. Neo-flo, Inc. with the FDA for Dry Tips.
Device ID | K890734 |
510k Number | K890734 |
Device Name: | DRY TIPS |
Classification | Absorber, Saliva, Paper |
Applicant | MICROCOPY, DIV. NEO-FLO, INC. 3120 MOON STATION RD. Kennesaw, GA 30144 |
Contact | Maass, Jr. |
Correspondent | Maass, Jr. MICROCOPY, DIV. NEO-FLO, INC. 3120 MOON STATION RD. Kennesaw, GA 30144 |
Product Code | KHR |
CFR Regulation Number | 872.6050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-13 |
Decision Date | 1989-03-10 |