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FDA 510(k)

TONGUE KLEAN

K-Number: K973175 · 1997-10-14

ApplicantSoftek Ent.
Decision Date1997-10-14
Product CodeLCN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TONGUE KLEAN is the device name listed in this FDA 510(k) record. The listed applicant is Softek Ent.. It received FDA 510(k) clearance on 1997-10-14 under 510(k) number K973175. The device is classified under product code LCN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONGUE KLEAN?

TONGUE KLEAN is a medical device that received FDA 510(k) clearance on 1997-10-14. The listed applicant is Softek Ent.. The 510(k) number is K973175.

When did TONGUE KLEAN receive FDA 510(k) clearance?

TONGUE KLEAN received FDA 510(k) clearance on 1997-10-14, under 510(k) number K973175.

Who is the listed applicant for TONGUE KLEAN?

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

What is the FDA product code for TONGUE KLEAN?

The FDA product code for TONGUE KLEAN is LCN.

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Related Devices (Code: LCN)

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.

K992270MIRACLEBREATH TONGUE CLEANERStellar Labs, Inc.K990344ORALGIENE TONGUE CLEANEROralgiene USA, Inc.K983683UNIK TONGUE CLEANERUnik Products, Inc.K983087BREATHTIQUE TONGUE SCRAPERCustom Medical Arts, Inc.K981808BREATHAID TONGUE SCRAPERBreathaid, LLCK980842COPPER TONGUE SCRAPEROntel Products Corp.

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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