The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Cone, Hand, Bk-1501.
Device ID | K760285 |
510k Number | K760285 |
Device Name: | CONE, HAND, BK-1501 |
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 | 1976-07-23 |
Decision Date | 1976-09-08 |