Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K864477Substantially Equivalent

Foundations Plus Girdle Support Garment 5000

Foundations Plus, Inc., Colleyville TX / Traditional, Substantially Equivalent

K864477 is the FDA 510(k) clearance record for FOUNDATIONS PLUS GIRDLE SUPPORT GARMENT 5000, cleared for Foundations Plus, Inc. on . FDA records list 4 510(k) clearances for Foundations Plus, Inc., from to . As of , FDA records show no recalls naming K864477.

Clearance record

Decision date
Received
(19 days to decision)
Review panel
Unknown
Applicant
Foundations Plus, Inc. 1008 Tinker Rd., Colleyville TX
Third party review
No