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FDA 510(k)

RELAX-O-GUARD

K-Number: K925064 · 1993-09-13

ApplicantAquatemp Service Co., Inc.
Decision Date1993-09-13
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent for Some Indications

Device Summary

RELAX-O-GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Aquatemp Service Co., Inc.. It received FDA 510(k) clearance on 1993-09-13 under 510(k) number K925064. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the RELAX-O-GUARD?

RELAX-O-GUARD is a medical device that received FDA 510(k) clearance on 1993-09-13. The listed applicant is Aquatemp Service Co., Inc.. The 510(k) number is K925064.

When did RELAX-O-GUARD receive FDA 510(k) clearance?

RELAX-O-GUARD received FDA 510(k) clearance on 1993-09-13, under 510(k) number K925064.

Who is the listed applicant for RELAX-O-GUARD?

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

What is the FDA product code for RELAX-O-GUARD?

The FDA product code for RELAX-O-GUARD 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 TechnologiesK924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERAmerican Orthodontics

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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