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FDA 510(k)

IMPRAFLO 3500 SERIES

K-Number: K904515 · 1990-12-04

ApplicantImpra, Inc.
Decision Date1990-12-04
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

IMPRAFLO 3500 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Impra, Inc.. It received FDA 510(k) clearance on 1990-12-04 under 510(k) number K904515. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPRAFLO 3500 SERIES?

IMPRAFLO 3500 SERIES is a medical device that received FDA 510(k) clearance on 1990-12-04. The listed applicant is Impra, Inc.. The 510(k) number is K904515.

When did IMPRAFLO 3500 SERIES receive FDA 510(k) clearance?

IMPRAFLO 3500 SERIES received FDA 510(k) clearance on 1990-12-04, under 510(k) number K904515.

Who is the listed applicant for IMPRAFLO 3500 SERIES?

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

What is the FDA product code for IMPRAFLO 3500 SERIES?

The FDA product code for IMPRAFLO 3500 SERIES is CAC.

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Other records listing Impra, 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.

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Related Devices (Code: CAC)

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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