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FDA 510(k)

HYBRID ARCTICGEL PAD

K-Number: K120849 · 2012-07-20

ApplicantMedivance, Inc.
Decision Date2012-07-20
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYBRID ARCTICGEL PAD is the device name listed in this FDA 510(k) record. The listed applicant is Medivance, Inc.. It received FDA 510(k) clearance on 2012-07-20 under 510(k) number K120849. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYBRID ARCTICGEL PAD?

HYBRID ARCTICGEL PAD is a medical device that received FDA 510(k) clearance on 2012-07-20. The listed applicant is Medivance, Inc.. The 510(k) number is K120849.

When did HYBRID ARCTICGEL PAD receive FDA 510(k) clearance?

HYBRID ARCTICGEL PAD received FDA 510(k) clearance on 2012-07-20, under 510(k) number K120849.

Who is the listed applicant for HYBRID ARCTICGEL PAD?

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

What is the FDA product code for HYBRID ARCTICGEL PAD?

The FDA product code for HYBRID ARCTICGEL PAD is DWJ.

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Other records listing Medivance, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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