The following data is part of a premarket notification filed by Wright Linear Pump, Inc. with the FDA for Linear Pump #4370975.
Device ID | K830577 |
510k Number | K830577 |
Device Name: | LINEAR PUMP #4370975 |
Classification | Sleeve, Limb, Compressible |
Applicant | WRIGHT LINEAR PUMP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-23 |
Decision Date | 1983-05-25 |