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FDA 510(k)

HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)

K-Number: K903613 · 1990-11-07

ApplicantHarvard Apparatus, Inc.
Decision Date1990-11-07
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) is the device name listed in this FDA 510(k) record. The listed applicant is Harvard Apparatus, Inc.. It received FDA 510(k) clearance on 1990-11-07 under 510(k) number K903613. 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 HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)?

HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) is a medical device that received FDA 510(k) clearance on 1990-11-07. The listed applicant is Harvard Apparatus, Inc.. The 510(k) number is K903613.

When did HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) receive FDA 510(k) clearance?

HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) received FDA 510(k) clearance on 1990-11-07, under 510(k) number K903613.

Who is the listed applicant for HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)?

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

What is the FDA product code for HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)?

The FDA product code for HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) is FLE.

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Other records listing Harvard Apparatus, 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.

K970678THE HARVARD LIBRARYK952794HARVARD 2 SYRINGE PUMPK903614HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVEK813644MODEL 2650 HIGH CAPACITY DUAL SYRINGEK801904SYRINGE INFUSION PUMP #2716K800569SYRINGE INFUSION PUMP #2720

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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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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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