The following data is part of a premarket notification filed by Lifemed Of California with the FDA for Lifemed Lifecoil Catheters.
Device ID | K841929 |
510k Number | K841929 |
Device Name: | LIFEMED LIFECOIL CATHETERS |
Classification | System, Peritoneal, Automatic Delivery |
Applicant | LIFEMED OF CALIFORNIA 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FKX |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-10 |
Decision Date | 1984-08-08 |