FDA 510(k)

DURAFINISH ALL-CURE, MODEL S296

K-Number: K080549 · 2008-05-13

Decision Date2008-05-13

Product CodeEBD

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DURAFINISH ALL-CURE, MODEL S296 is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2008-05-13 under 510(k) number K080549. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAFINISH ALL-CURE, MODEL S296?

DURAFINISH ALL-CURE, MODEL S296 is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Parkell, Inc.. The 510(k) number is K080549.

When did DURAFINISH ALL-CURE, MODEL S296 receive FDA 510(k) clearance?

DURAFINISH ALL-CURE, MODEL S296 received FDA 510(k) clearance on 2008-05-13, under 510(k) number K080549.

Who is the listed applicant for DURAFINISH ALL-CURE, MODEL S296?

The FDA 510(k) record lists Parkell, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURAFINISH ALL-CURE, MODEL S296?

The FDA product code for DURAFINISH ALL-CURE, MODEL S296 is EBD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.