The following data is part of a premarket notification filed by Wright Linear Pump, Inc. with the FDA for Wlp Single-segment Version Wlp Solo Vii.
| Device ID | K961891 |
| 510k Number | K961891 |
| Device Name: | WLP SINGLE-SEGMENT VERSION WLP SOLO VII |
| Classification | Sleeve, Limb, Compressible |
| Applicant | WRIGHT LINEAR PUMP, INC. 408 NORTH TAYLOR AVE. Pittsburgh, PA 15212 |
| Contact | Joe Soriero |
| Correspondent | Joe Soriero WRIGHT LINEAR PUMP, INC. 408 NORTH TAYLOR AVE. Pittsburgh, PA 15212 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-11-06 |
| Summary: | summary |