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FDA 510(k)

PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003

K-Number: K042947 · 2004-12-27

ApplicantArthrocare Corp.
Decision Date2004-12-27
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2004-12-27 under 510(k) number K042947. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003?

PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 is a medical device that received FDA 510(k) clearance on 2004-12-27. The listed applicant is Arthrocare Corp.. The 510(k) number is K042947.

When did PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 receive FDA 510(k) clearance?

PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 received FDA 510(k) clearance on 2004-12-27, under 510(k) number K042947.

Who is the listed applicant for PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003?

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

What is the FDA product code for PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003?

The FDA product code for PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 is NDN.

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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.

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