510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K830111Substantially Equivalent

Septocal

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

K830111 is the FDA 510(k) clearance record for SEPTOCAL, cleared for North Pacific Dental, Inc. on . FDA records list 11 510(k) clearances for North Pacific Dental, Inc., from to . As of , FDA records show no recalls naming K830111.

Clearance record

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