The following data is part of a premarket notification filed by Fred Sammons, Inc. with the FDA for Bk-5371 Gad-19-bout Personal Mobil Aid.
| Device ID | K790173 |
| 510k Number | K790173 |
| Device Name: | BK-5371 GAD-19-BOUT PERSONAL MOBIL AID |
| Classification | Utensil, Homemaking |
| Applicant | FRED SAMMONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IKW |
| CFR Regulation Number | 890.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-26 |
| Decision Date | 1979-02-22 |