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FDA 510(k)

CONTORNO(R), MODELS E AND ST

K-Number: K905108 · 1991-02-04

ApplicantPalex Intl. SA
Decision Date1991-02-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONTORNO(R), MODELS E AND ST is the device name listed in this FDA 510(k) record. The listed applicant is Palex Intl. SA. It received FDA 510(k) clearance on 1991-02-04 under 510(k) number K905108. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTORNO(R), MODELS E AND ST?

CONTORNO(R), MODELS E AND ST is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Palex Intl. SA. The 510(k) number is K905108.

When did CONTORNO(R), MODELS E AND ST receive FDA 510(k) clearance?

CONTORNO(R), MODELS E AND ST received FDA 510(k) clearance on 1991-02-04, under 510(k) number K905108.

Who is the listed applicant for CONTORNO(R), MODELS E AND ST?

The FDA 510(k) record lists Palex Intl. SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTORNO(R), MODELS E AND ST?

The FDA product code for CONTORNO(R), MODELS E AND ST is GEI.

Related Clinical Trials

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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Other records listing Palex Intl. SA 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.

K904586PALEX IRRIGATION SETK903224EPISENSORK902642CONTORNO (TM)K901680BAUMAN RIGID LARYNGOSCOPE

Related Devices (Code: GEI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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