FDA 510(k)

PASSAGE AIRWAY SPLINT

K-Number: K901307 · 1990-06-14

Decision Date1990-06-14

Product CodeLYA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

PASSAGE AIRWAY SPLINT 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 1990-06-14 under 510(k) number K901307. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSAGE AIRWAY SPLINT?

PASSAGE AIRWAY SPLINT is a medical device that received FDA 510(k) clearance on 1990-06-14. The listed applicant is Invotec International, Inc.. The 510(k) number is K901307.

When did PASSAGE AIRWAY SPLINT receive FDA 510(k) clearance?

PASSAGE AIRWAY SPLINT received FDA 510(k) clearance on 1990-06-14, under 510(k) number K901307.

Who is the listed applicant for PASSAGE AIRWAY SPLINT?

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 PASSAGE AIRWAY SPLINT?

The FDA product code for PASSAGE AIRWAY SPLINT is LYA.

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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.