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FDA 510(k)

VENTIL-A ORAL PROTECTOR

K-Number: K992269 · 1999-10-25

ApplicantSomatics, Inc.
Decision Date1999-10-25
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VENTIL-A ORAL PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Somatics, Inc.. It received FDA 510(k) clearance on 1999-10-25 under 510(k) number K992269. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTIL-A ORAL PROTECTOR?

VENTIL-A ORAL PROTECTOR is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Somatics, Inc.. The 510(k) number is K992269.

When did VENTIL-A ORAL PROTECTOR receive FDA 510(k) clearance?

VENTIL-A ORAL PROTECTOR received FDA 510(k) clearance on 1999-10-25, under 510(k) number K992269.

Who is the listed applicant for VENTIL-A ORAL PROTECTOR?

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

What is the FDA product code for VENTIL-A ORAL PROTECTOR?

The FDA product code for VENTIL-A ORAL PROTECTOR is JXL.

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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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