The following data is part of a premarket notification filed by Albahealth Llc with the FDA for Pulstar Logix Pump.
| Device ID | K141609 |
| 510k Number | K141609 |
| Device Name: | PULSTAR LOGIX PUMP |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ALBAHEALTH LLC 425 N GATEWAY AVE. Rockwood, TN 37854 |
| Contact | Shane Bruce |
| Correspondent | Shane Bruce ALBAHEALTH LLC 425 N GATEWAY AVE. Rockwood, TN 37854 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-16 |
| Decision Date | 2014-07-15 |