The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Flowplus Ac330 Pump Garments.
| Device ID | K910188 |
| 510k Number | K910188 |
| Device Name: | FLOWPLUS AC330 PUMP GARMENTS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko 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 | 1991-01-16 |
| Decision Date | 1991-05-28 |