510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820628Substantially Equivalent

J-Catheter

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

K820628 is the FDA 510(k) clearance record for J-CATHETER, cleared for Dna Medical, Inc. on . FDA records list 5 510(k) clearances for Dna Medical, Inc., from to . As of , FDA records show no recalls naming K820628.

Clearance record

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