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FDA 510(k)

8 FRENCH DILATOR 15CM, W/LUER LOCK

K-Number: K833965 · 1983-12-16

ApplicantQuinton, Inc.
Decision Date1983-12-16
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8 FRENCH DILATOR 15CM, W/LUER LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1983-12-16 under 510(k) number K833965. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8 FRENCH DILATOR 15CM, W/LUER LOCK?

8 FRENCH DILATOR 15CM, W/LUER LOCK is a medical device that received FDA 510(k) clearance on 1983-12-16. The listed applicant is Quinton, Inc.. The 510(k) number is K833965.

When did 8 FRENCH DILATOR 15CM, W/LUER LOCK receive FDA 510(k) clearance?

8 FRENCH DILATOR 15CM, W/LUER LOCK received FDA 510(k) clearance on 1983-12-16, under 510(k) number K833965.

Who is the listed applicant for 8 FRENCH DILATOR 15CM, W/LUER LOCK?

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

What is the FDA product code for 8 FRENCH DILATOR 15CM, W/LUER LOCK?

The FDA product code for 8 FRENCH DILATOR 15CM, W/LUER LOCK is DRE.

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Other records listing Quinton, Inc. as applicant

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Related Devices (Code: DRE)

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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