Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K853460Substantially Equivalent

Endo L 300 Light, Illuminating Wound Rectractor

Heraeus, Inc., West Conshohocken PA / Traditional, Substantially Equivalent

K853460 is the FDA 510(k) clearance record for ENDO L 300 LIGHT, ILLUMINATING WOUND RECTRACTOR, cleared for Heraeus, Inc. on . FDA records list one 510(k) clearance for Heraeus, Inc. As of , FDA records show no recalls naming K853460.

Clearance record

Decision date
Received
(17 days to decision)
Review panel
Unknown
Applicant
Heraeus, Inc. Union Hill, West Conshohocken PA
Third party review
No