The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Medipart Filter & Tubing Mp-02x.
Device ID | K844491 |
510k Number | K844491 |
Device Name: | MEDIPART FILTER & TUBING MP-02X |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
Contact | Jerry A Alexander |
Correspondent | Jerry A Alexander MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-11-20 |
Decision Date | 1984-12-04 |