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FDA 510(k)

SALIVA-STIM

K-Number: K914892 · 1992-09-02

ApplicantOrion Diagnostica, Inc.
Decision Date1992-09-02
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SALIVA-STIM is the device name listed in this FDA 510(k) record. The listed applicant is Orion Diagnostica, Inc.. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K914892. The device is classified under product code EGD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALIVA-STIM?

SALIVA-STIM is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is Orion Diagnostica, Inc.. The 510(k) number is K914892.

When did SALIVA-STIM receive FDA 510(k) clearance?

SALIVA-STIM received FDA 510(k) clearance on 1992-09-02, under 510(k) number K914892.

Who is the listed applicant for SALIVA-STIM?

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

What is the FDA product code for SALIVA-STIM?

The FDA product code for SALIVA-STIM is EGD.

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Other records listing Orion Diagnostica, Inc. as applicant

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Related Devices (Code: EGD)

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.

K020009BRACE EZEUdent, Inc.K945535GLENROE ORTHO-SILGlenroe TechnologiesK924024ORTHO WAXHeraeus Kulzer, Inc.K923586BURNOUT MATERIALDentsply Intl.K922380BITE RIM WAXDentsply Intl.K914513PALAVIT GHeraeus Kulzer, Inc.

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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