The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Flowtron Universal, Model Ac600.
| Device ID | K010744 |
| 510k Number | K010744 |
| Device Name: | FLOWTRON UNIVERSAL, MODEL AC600 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Audry Witko |
| Correspondent | Audry 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 | 2001-03-13 |
| Decision Date | 2002-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055982700146 | K010744 | 000 |
| 05055982700139 | K010744 | 000 |