Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K864804Substantially Equivalent

Cloward Disposable Armrests and Face Rest

Surgical Equipment International, Inc., Honolulu HI / Traditional, Substantially Equivalent

K864804 is the FDA 510(k) clearance record for CLOWARD DISPOSABLE ARMRESTS AND FACE REST, cleared for Surgical Equipment International, Inc. on . FDA records list 2 510(k) clearances for Surgical Equipment International, Inc. As of , FDA records show no recalls naming K864804.

Clearance record

Decision date
Received
(15 days to decision)
Review panel
Unknown
Applicant
Surgical Equipment International, Inc. 1670 Halekoa Dr., Honolulu HI
Third party review
No