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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K864528Substantially Equivalent

Towels

Elof Hansson, Inc., Norwalk CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864528 is the FDA 510(k) clearance record for TOWELS, cleared for Elof Hansson, Inc. on . FDA records list 2 510(k) clearances for Elof Hansson, Inc., from to . As of , FDA records show no recalls naming K864528.

Clearance record

Decision date
Received
(31 days to decision)
Review panel
Unknown
Applicant
Elof Hansson, Inc. 25 Van Zant St., Norwalk CT
Third party review
No