The following data is part of a premarket notification filed by Kaye Products, Inc. with the FDA for Kaye Model Kiao Pelvic/thigh Stabilizer.
Device ID | K923095 |
510k Number | K923095 |
Device Name: | KAYE MODEL KIAO PELVIC/THIGH STABILIZER |
Classification | Chair, Adjustable, Mechanical |
Applicant | KAYE PRODUCTS, INC. 535 DIMMOCKS MILL RD. Hillsborough, NC 27278 |
Contact | H, Bagshawe |
Correspondent | H, Bagshawe KAYE PRODUCTS, INC. 535 DIMMOCKS MILL RD. Hillsborough, NC 27278 |
Product Code | INN |
CFR Regulation Number | 890.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-25 |
Decision Date | 1992-07-21 |