The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Bk-1544 Be Ok Scoop Disk.
Device ID | K800019 |
510k Number | K800019 |
Device Name: | BK-1544 BE OK SCOOP DISK |
Classification | Utensil, Eating |
Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILC |
CFR Regulation Number | 890.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-02 |
Decision Date | 1980-01-21 |