The following data is part of a premarket notification filed by Wright Linear Pump, Inc. with the FDA for Wright Gradient Pressure Support Stockings.
Device ID | K883186 |
510k Number | K883186 |
Device Name: | WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | WRIGHT LINEAR PUMP, INC. 185A ROBINSON RD. Imperial, PA 15126 |
Contact | Wright |
Correspondent | Wright WRIGHT LINEAR PUMP, INC. 185A ROBINSON RD. Imperial, PA 15126 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-28 |
Decision Date | 1988-11-21 |