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FDA 510(k)

SHOWERFLOSS ORAL IRRIGATION UNIT

K-Number: K922307 · 1992-06-16

ApplicantShowerfloss, Inc.
Decision Date1992-06-16
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SHOWERFLOSS ORAL IRRIGATION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Showerfloss, Inc.. It received FDA 510(k) clearance on 1992-06-16 under 510(k) number K922307. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHOWERFLOSS ORAL IRRIGATION UNIT?

SHOWERFLOSS ORAL IRRIGATION UNIT is a medical device that received FDA 510(k) clearance on 1992-06-16. The listed applicant is Showerfloss, Inc.. The 510(k) number is K922307.

When did SHOWERFLOSS ORAL IRRIGATION UNIT receive FDA 510(k) clearance?

SHOWERFLOSS ORAL IRRIGATION UNIT received FDA 510(k) clearance on 1992-06-16, under 510(k) number K922307.

Who is the listed applicant for SHOWERFLOSS ORAL IRRIGATION UNIT?

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

What is the FDA product code for SHOWERFLOSS ORAL IRRIGATION UNIT?

The FDA product code for SHOWERFLOSS ORAL IRRIGATION UNIT is EFS.

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Related Devices (Code: EFS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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