The following data is part of a premarket notification filed by Tang Products with the FDA for Super Slick.
Device ID | K853882 |
510k Number | K853882 |
Device Name: | SUPER SLICK |
Classification | Tray, Fluoride, Disposable |
Applicant | TANG PRODUCTS P.O. BOX 440972 Aurora, CO 80044 |
Contact | John Halfen |
Correspondent | John Halfen TANG PRODUCTS P.O. BOX 440972 Aurora, CO 80044 |
Product Code | KMT |
CFR Regulation Number | 872.6870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-19 |
Decision Date | 1985-11-18 |