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FDA 510(k)

DERMA HOOD

K-Number: K131338 · 2013-07-10

Decision Date2013-07-10
Product CodePEQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMA HOOD is the device name listed in this FDA 510(k) record. The listed applicant is Globalmedia Group, LLC. It received FDA 510(k) clearance on 2013-07-10 under 510(k) number K131338. The device is classified under product code PEQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMA HOOD?

DERMA HOOD is a medical device that received FDA 510(k) clearance on 2013-07-10. The listed applicant is Globalmedia Group, LLC. The 510(k) number is K131338.

When did DERMA HOOD receive FDA 510(k) clearance?

DERMA HOOD received FDA 510(k) clearance on 2013-07-10, under 510(k) number K131338.

Who is the listed applicant for DERMA HOOD?

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

What is the FDA product code for DERMA HOOD?

The FDA product code for DERMA HOOD is PEQ.

Related Clinical Trials

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.

Official Source

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