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FDA 510(k)

INVOTEC BI-VALVE SPLINT

K-Number: K901306 · 1990-06-14

ApplicantInvotec International, Inc.
Decision Date1990-06-14
Product CodeLYA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INVOTEC BI-VALVE 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 K901306. 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 INVOTEC BI-VALVE SPLINT?

INVOTEC BI-VALVE 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 K901306.

When did INVOTEC BI-VALVE SPLINT receive FDA 510(k) clearance?

INVOTEC BI-VALVE SPLINT received FDA 510(k) clearance on 1990-06-14, under 510(k) number K901306.

Who is the listed applicant for INVOTEC BI-VALVE 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 INVOTEC BI-VALVE SPLINT?

The FDA product code for INVOTEC BI-VALVE SPLINT is LYA.

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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.

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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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