The following data is part of a premarket notification filed by Wright Linear Pump, Inc. with the FDA for Wlp Gradient Sequential Version/wlp Prolite/wlp Wlp-ii Lite.
Device ID | K961797 |
510k Number | K961797 |
Device Name: | WLP GRADIENT SEQUENTIAL VERSION/WLP PROLITE/WLP WLP-II LITE |
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 |