510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K863777Substantially Equivalent

B-Wrap

Bdf Plaza, Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863777 is the FDA 510(k) clearance record for B-WRAP, cleared for Bdf Plaza on . FDA records list one 510(k) clearance for Bdf Plaza. As of , FDA records show no recalls naming K863777.

Clearance record

Decision date
Received
(28 days to decision)
Review panel
Unknown
Applicant
Bdf Plaza Bdf Plz., Norwalk CT
Third party review
No