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FDA 510(k)

NormaTec PCD-T and PCD-B

K-Number: K161346 · 2016-06-15

ApplicantNormaTec Industries, LP
Decision Date2016-06-15
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NormaTec PCD-T and PCD-B is the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2016-06-15 under 510(k) number K161346. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NormaTec PCD-T and PCD-B?

NormaTec PCD-T and PCD-B is a medical device that received FDA 510(k) clearance on 2016-06-15. The listed applicant is NormaTec Industries, LP. The 510(k) number is K161346.

When did NormaTec PCD-T and PCD-B receive FDA 510(k) clearance?

NormaTec PCD-T and PCD-B received FDA 510(k) clearance on 2016-06-15, under 510(k) number K161346.

Who is the listed applicant for NormaTec PCD-T and PCD-B?

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

What is the FDA product code for NormaTec PCD-T and PCD-B?

The FDA product code for NormaTec PCD-T and PCD-B is JOW.

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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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