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FDA 510(k)

ULTRADENT CARBON MASK - UPI #342

K-Number: K041047 · 2004-12-01

ApplicantMedspring Group, Incorporated
Decision Date2004-12-01
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRADENT CARBON MASK - UPI #342 is the device name listed in this FDA 510(k) record. The listed applicant is Medspring Group, Incorporated. It received FDA 510(k) clearance on 2004-12-01 under 510(k) number K041047. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRADENT CARBON MASK - UPI #342?

ULTRADENT CARBON MASK - UPI #342 is a medical device that received FDA 510(k) clearance on 2004-12-01. The listed applicant is Medspring Group, Incorporated. The 510(k) number is K041047.

When did ULTRADENT CARBON MASK - UPI #342 receive FDA 510(k) clearance?

ULTRADENT CARBON MASK - UPI #342 received FDA 510(k) clearance on 2004-12-01, under 510(k) number K041047.

Who is the listed applicant for ULTRADENT CARBON MASK - UPI #342?

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

What is the FDA product code for ULTRADENT CARBON MASK - UPI #342?

The FDA product code for ULTRADENT CARBON MASK - UPI #342 is FXX.

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Related Devices (Code: FXX)

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Official Source

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

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