OXYGEN/NITROUS OXIDE OUTLET

Yoke Assembly, Medical Gas

SPICA, INC.

The following data is part of a premarket notification filed by Spica, Inc. with the FDA for Oxygen/nitrous Oxide Outlet.

Pre-market Notification Details

Device IDK780365
510k NumberK780365
Device Name:OXYGEN/NITROUS OXIDE OUTLET
ClassificationYoke Assembly, Medical Gas
Applicant SPICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAM  
CFR Regulation Number868.6885 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-03-06
Decision Date1978-03-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.