Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K827291Substantially Equivalent

Model Pup II and Mini-Nebulizer

Biermar AG, Walker MI / Traditional, Substantially Equivalent

K827291 is the FDA 510(k) clearance record for MODEL PUP II AND MINI-NEBULIZER, cleared for Biermar AG on . FDA records list one 510(k) clearance for Biermar AG. As of , FDA records show no recalls naming K827291.

Clearance record

Decision date
Received
(22 days to decision)
Review panel
Unknown
Applicant
Biermar AG 4221 Richmond Rd., NW, Walker MI
Third party review
No