Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K863279Substantially Equivalent

Surgi-Tek Tube Positioner

Dermacare Products, Inc., Louisville KT / Traditional, Substantially Equivalent

K863279 is the FDA 510(k) clearance record for SURGI-TEK TUBE POSITIONER, cleared for Dermacare Products, Inc. on . FDA records list 8 510(k) clearances for Dermacare Products, Inc., from to . As of , FDA records show no recalls naming K863279.

Clearance record

Decision date
Received
(15 days to decision)
Review panel
Unknown
Applicant
Dermacare Products, Inc. 7651 National Tpke., Louisville KT
Third party review
No