The following data is part of a premarket notification filed by Hill Laboratories Co. with the FDA for Healthstar Elite.
| Device ID | K043239 |
| 510k Number | K043239 |
| Device Name: | HEALTHSTAR ELITE |
| Classification | Equipment, Traction, Powered |
| Applicant | HILL LABORATORIES CO. 3 BACTON HILL RD. P.O. BOX 2028 Frazer, PA 19355 |
| Contact | Howard A Hill |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-11-23 |
| Decision Date | 2004-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001452518 | K043239 | 000 |
| 00860001452501 | K043239 | 000 |