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FDA 510(k)

AUTOLOGOUS BLOOD PROCESSING SYSTEM

K-Number: K913181 · 1992-05-20

ApplicantLifestream Int'L, Inc.
Decision Date1992-05-20
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTOLOGOUS BLOOD PROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1992-05-20 under 510(k) number K913181. 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 AUTOLOGOUS BLOOD PROCESSING SYSTEM?

AUTOLOGOUS BLOOD PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 1992-05-20. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K913181.

When did AUTOLOGOUS BLOOD PROCESSING SYSTEM receive FDA 510(k) clearance?

AUTOLOGOUS BLOOD PROCESSING SYSTEM received FDA 510(k) clearance on 1992-05-20, under 510(k) number K913181.

Who is the listed applicant for AUTOLOGOUS BLOOD PROCESSING SYSTEM?

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

What is the FDA product code for AUTOLOGOUS BLOOD PROCESSING SYSTEM?

The FDA product code for AUTOLOGOUS BLOOD PROCESSING SYSTEM is CAC.

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Other records listing Lifestream Int'L, Inc. as applicant

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K964571VISION CARDIOPLEGIA DELIVERY SYSTEMK962354DIOMED 15, 30, 60 SURGICAL DIODE LASERK920178CARDIOTOMY RESERVOIR W/20 MICRON FILITERK920618AUTOTRANSFUSION SUCTION SETK914396SURGI LIGHT NON-CONTACT FIBERSK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST

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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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