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FDA 510(k)

OLYMPUS VALVULOTOME W/FIXED TIP

K-Number: K894496 · 1989-10-12

ApplicantOlympus Corp.
Decision Date1989-10-12
Product CodeDWX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OLYMPUS VALVULOTOME W/FIXED TIP is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Corp.. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K894496. The device is classified under product code DWX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS VALVULOTOME W/FIXED TIP?

OLYMPUS VALVULOTOME W/FIXED TIP is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Olympus Corp.. The 510(k) number is K894496.

When did OLYMPUS VALVULOTOME W/FIXED TIP receive FDA 510(k) clearance?

OLYMPUS VALVULOTOME W/FIXED TIP received FDA 510(k) clearance on 1989-10-12, under 510(k) number K894496.

Who is the listed applicant for OLYMPUS VALVULOTOME W/FIXED TIP?

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

What is the FDA product code for OLYMPUS VALVULOTOME W/FIXED TIP?

The FDA product code for OLYMPUS VALVULOTOME W/FIXED TIP is DWX.

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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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