510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822770Substantially Equivalent

Burlington Stockinette

Balfour, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822770 is the FDA 510(k) clearance record for BURLINGTON STOCKINETTE, cleared for Balfour, Inc. on . FDA records list 3 510(k) clearances for Balfour, Inc., from to . As of , FDA records show no recalls naming K822770.

Clearance record

Decision date
Received
(315 days to decision)
Review panel
Unknown
Applicant
Balfour, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No