The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for 6-435 Filter Pad, 5/pkg..
Device ID | K802914 |
510k Number | K802914 |
Device Name: | 6-435 FILTER PAD, 5/PKG. |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | LIFECARE SERVICES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-18 |
Decision Date | 1980-12-19 |