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FDA 510(k)

PANA SPRAY Plus

K-Number: K163483 · 2017-08-15

ApplicantNakanishi, Inc.
Decision Date2017-08-15
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANA SPRAY Plus is the device name listed in this FDA 510(k) record. The listed applicant is Nakanishi, Inc.. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K163483. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANA SPRAY Plus?

PANA SPRAY Plus is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is Nakanishi, Inc.. The 510(k) number is K163483.

When did PANA SPRAY Plus receive FDA 510(k) clearance?

PANA SPRAY Plus received FDA 510(k) clearance on 2017-08-15, under 510(k) number K163483.

Who is the listed applicant for PANA SPRAY Plus?

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

What is the FDA product code for PANA SPRAY Plus?

The FDA product code for PANA SPRAY Plus is EFB.

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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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