Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K871138Substantially Equivalent for Some Indications

Foundations Plus Abdominal Band 1100

Foundations Plus, Inc., Colleyville TX / Traditional, Substantially Equivalent for Some Indications

K871138 is the FDA 510(k) clearance record for FOUNDATIONS PLUS ABDOMINAL BAND 1100, 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 K871138.

Clearance record

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