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FDA 510(k)

INVOTEC POLY-MESH MANDIBULAR TRAY

K-Number: K901923 · 1990-10-31

ApplicantInvotec International, Inc.
Decision Date1990-10-31
Product CodeJAZ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INVOTEC POLY-MESH MANDIBULAR TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 1990-10-31 under 510(k) number K901923. The device is classified under product code JAZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVOTEC POLY-MESH MANDIBULAR TRAY?

INVOTEC POLY-MESH MANDIBULAR TRAY is a medical device that received FDA 510(k) clearance on 1990-10-31. The listed applicant is Invotec International, Inc.. The 510(k) number is K901923.

When did INVOTEC POLY-MESH MANDIBULAR TRAY receive FDA 510(k) clearance?

INVOTEC POLY-MESH MANDIBULAR TRAY received FDA 510(k) clearance on 1990-10-31, under 510(k) number K901923.

Who is the listed applicant for INVOTEC POLY-MESH MANDIBULAR TRAY?

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

What is the FDA product code for INVOTEC POLY-MESH MANDIBULAR TRAY?

The FDA product code for INVOTEC POLY-MESH MANDIBULAR TRAY is JAZ.

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Other records listing Invotec International, Inc. as applicant

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.

K122040INVOTEC LARYNGEAL ELECTRODEK080740CLEARVIEW ENDOSCOPE COVERK030492TITANIUM OSSICULAR REPLACMENT SYSTEMK973580INVOTEC CLEAN PADK973578INVOTEC EAR TAMPON (WICK) W/STRINGK971000EPISTAXIS NASAL PACK

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Related Devices (Code: JAZ)

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.

K821904XOMED MANDIBULAR TRAYXomed, 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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