The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Filter, Bacteria (#2290).
Device ID | K760081 |
510k Number | K760081 |
Device Name: | FILTER, BACTERIA (#2290) |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | INSPIRON CORP. 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 | 1976-06-21 |
Decision Date | 1976-07-15 |