Primus Sterilizer Company, LLC FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)510(k)Dec 19, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Dec 19, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HC)510(k)Feb 10, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Abbreviated)	Feb 10, 2023