The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Flowtron Dvt System Ac500 Pump, L501 Garment.
| Device ID | K881632 |
| 510k Number | K881632 |
| Device Name: | FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Contact | James Britton |
| Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-14 |
| Decision Date | 1988-09-26 |