510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K827448Substantially Equivalent

Bsinus Diaphanograph

Sinus Medical, Inc., Ft Lauderdale FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827448 is the FDA 510(k) clearance record for BSINUS DIAPHANOGRAPH, cleared for Sinus Medical, Inc. on . FDA records list one 510(k) clearance for Sinus Medical, Inc. As of , FDA records show no recalls naming K827448.

Clearance record

Decision date
Received
(27 days to decision)
Review panel
Unknown
Applicant
Sinus Medical, Inc. 1915 NE 45th St., Ft Lauderdale FL
Third party review
No