The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Kaye Scoot-about, Model Sb1.
| Device ID | K924848 |
| 510k Number | K924848 |
| Device Name: | KAYE SCOOT-ABOUT, MODEL SB1 |
| Classification | Chair, With Casters |
| Applicant | KAYE PRODUCTS, INC. 535 DIMMOCKS MILL RD. Hillsborough, NC 27278 |
| Contact | Lilla H Bagshawe |
| Correspondent | Lilla H Bagshawe KAYE PRODUCTS, INC. 535 DIMMOCKS MILL RD. Hillsborough, NC 27278 |
| Product Code | INM |
| CFR Regulation Number | 890.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-28 |
| Decision Date | 1993-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810117142957 | K924848 | 000 |
| 00810117142940 | K924848 | 000 |