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 |