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FDA 510(k)

EAGLE CENTURY STEAM STERILIZER

K-Number: K964332 · 1998-06-01

ApplicantAmsco Intl., Inc.
Decision Date1998-06-01
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EAGLE CENTURY STEAM STERILIZER is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Intl., Inc.. It received FDA 510(k) clearance on 1998-06-01 under 510(k) number K964332. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAGLE CENTURY STEAM STERILIZER?

EAGLE CENTURY STEAM STERILIZER is a medical device that received FDA 510(k) clearance on 1998-06-01. The listed applicant is Amsco Intl., Inc.. The 510(k) number is K964332.

When did EAGLE CENTURY STEAM STERILIZER receive FDA 510(k) clearance?

EAGLE CENTURY STEAM STERILIZER received FDA 510(k) clearance on 1998-06-01, under 510(k) number K964332.

Who is the listed applicant for EAGLE CENTURY STEAM STERILIZER?

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

What is the FDA product code for EAGLE CENTURY STEAM STERILIZER?

The FDA product code for EAGLE CENTURY STEAM STERILIZER is FLE.

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Related Devices (Code: FLE)

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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