Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K831531Substantially Equivalent

Surgical Isolation Barrier System

Lone Star Medical Products, Walker MI / Traditional, Substantially Equivalent

K831531 is the FDA 510(k) clearance record for SURGICAL ISOLATION BARRIER SYSTEM, cleared for Lone Star Medical Products, Inc. on . FDA records list 6 510(k) clearances for Lone Star Medical Products, Inc., from to . As of , FDA records show no recalls naming K831531.

Clearance record

Decision date
Received
(391 days to decision)
Review panel
Unknown
Applicant
Lone Star Medical Products, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No