The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Sts Range , Models Sts20,sts30,sts40.
| Device ID | K012008 |
| 510k Number | K012008 |
| Device Name: | STS RANGE , MODELS STS20,STS30,STS40 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-27 |
| Decision Date | 2001-09-21 |
| Summary: | summary |