The following data is part of a premarket notification filed by Wright Linear Pump, Inc. with the FDA for Wright Model 51 And 52 Sequential Compression Systems.
Device ID | K071040 |
510k Number | K071040 |
Device Name: | WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS |
Classification | Sleeve, Limb, Compressible |
Applicant | WRIGHT LINEAR PUMP, INC. 103-B INTERNATIONAL DR. Oakdale, PA 15071 -3907 |
Contact | Carol Wright |
Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-04-12 |
Decision Date | 2007-05-22 |
Summary: | summary |