The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Bottle, Condensate (#1628).
Device ID | K760082 |
510k Number | K760082 |
Device Name: | BOTTLE, CONDENSATE (#1628) |
Classification | Bottle, Collection And Trap, Breathing System (uncalibrated) |
Applicant | INSPIRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBC |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-21 |
Decision Date | 1976-07-16 |