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FDA 510(k)

HEALTH MASK

K-Number: K070467 · 2007-04-17

ApplicantPolar Wrap, LLC
Decision Date2007-04-17
Product CodeOBN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEALTH MASK is the device name listed in this FDA 510(k) record. The listed applicant is Polar Wrap, LLC. It received FDA 510(k) clearance on 2007-04-17 under 510(k) number K070467. The device is classified under product code OBN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALTH MASK?

HEALTH MASK is a medical device that received FDA 510(k) clearance on 2007-04-17. The listed applicant is Polar Wrap, LLC. The 510(k) number is K070467.

When did HEALTH MASK receive FDA 510(k) clearance?

HEALTH MASK received FDA 510(k) clearance on 2007-04-17, under 510(k) number K070467.

Who is the listed applicant for HEALTH MASK?

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

What is the FDA product code for HEALTH MASK?

The FDA product code for HEALTH MASK is OBN.

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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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