510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780927Substantially Equivalent

Ti-Comforter

Alden Products Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780927 is the FDA 510(k) clearance record for TI-COMFORTER, cleared for Alden Products Co. on . FDA records list one 510(k) clearance for Alden Products Co. As of , FDA records show no recalls naming K780927.

Clearance record

Decision date
Received
(65 days to decision)
Review panel
Unknown
Applicant
Alden Products Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No