The following data is part of a premarket notification filed by Medipart Jerry Alexander with the FDA for Medipart Bacteria Filter Mp-2615.
Device ID | K853577 |
510k Number | K853577 |
Device Name: | MEDIPART BACTERIA FILTER MP-2615 |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | MEDIPART JERRY ALEXANDER 607 SPRING BEACH RD. Cary, IL 60013 |
Contact | Jerry Alexander |
Correspondent | Jerry 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 | 1985-08-26 |
Decision Date | 1985-10-30 |