510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K853491Substantially Equivalent

Reusable Dextra Synovial Resectors in 3.5/4.5/5.5M

Chattanooga Group, Inc., Red Bank TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853491 is the FDA 510(k) clearance record for REUSABLE DEXTRA SYNOVIAL RESECTORS IN 3.5/4.5/5.5M, cleared for Chattanooga Group, Inc. on . FDA records list 81 510(k) clearances for Chattanooga Group, Inc., from to . As of , FDA records show no recalls naming K853491.

Clearance record

Decision date
Received
(17 days to decision)
Review panel
Unknown
Applicant
Chattanooga Group, Inc. 101 Memorial Dr., Red Bank TN
Third party review
No