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FDA 510(k)

AQUALIZER MOUTHPIECE

K-Number: K831793 · 1983-08-12

ApplicantMartin D. Lerman
Decision Date1983-08-12
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AQUALIZER MOUTHPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Martin D. Lerman. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K831793. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUALIZER MOUTHPIECE?

AQUALIZER MOUTHPIECE is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Martin D. Lerman. The 510(k) number is K831793.

When did AQUALIZER MOUTHPIECE receive FDA 510(k) clearance?

AQUALIZER MOUTHPIECE received FDA 510(k) clearance on 1983-08-12, under 510(k) number K831793.

Who is the listed applicant for AQUALIZER MOUTHPIECE?

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

What is the FDA product code for AQUALIZER MOUTHPIECE?

The FDA product code for AQUALIZER MOUTHPIECE is KMY.

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Related Devices (Code: KMY)

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.

K931615NITE-GUIDEORTHO-TAIN, Inc.K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.K924351GLENROE ELASTIBITE STIMULATORGlenroe TechnologiesK925064RELAX-O-GUARDAquatemp Service Co., Inc.K924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.

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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