The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Adaptive Pens & Lap Desk.
Device ID | K831546 |
510k Number | K831546 |
Device Name: | ADAPTIVE PENS & LAP DESK |
Classification | System, Communication, Non-powered |
Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILP |
CFR Regulation Number | 890.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-12 |
Decision Date | 1983-06-08 |