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FDA 510(k)

CUSTOM INSTRUMENT DRAPE

K-Number: K843890 · 1984-10-26

ApplicantLifestream Int'L, Inc.
Decision Date1984-10-26
Product CodeHMW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUSTOM INSTRUMENT DRAPE 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 1984-10-26 under 510(k) number K843890. The device is classified under product code HMW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM INSTRUMENT DRAPE?

CUSTOM INSTRUMENT DRAPE is a medical device that received FDA 510(k) clearance on 1984-10-26. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K843890.

When did CUSTOM INSTRUMENT DRAPE receive FDA 510(k) clearance?

CUSTOM INSTRUMENT DRAPE received FDA 510(k) clearance on 1984-10-26, under 510(k) number K843890.

Who is the listed applicant for CUSTOM INSTRUMENT DRAPE?

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 CUSTOM INSTRUMENT DRAPE?

The FDA product code for CUSTOM INSTRUMENT DRAPE is HMW.

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Other records listing Lifestream Int'L, 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.

K964571VISION CARDIOPLEGIA DELIVERY SYSTEMK962354DIOMED 15, 30, 60 SURGICAL DIODE LASERK920178CARDIOTOMY RESERVOIR W/20 MICRON FILITERK920618AUTOTRANSFUSION SUCTION SETK913181AUTOLOGOUS BLOOD PROCESSING SYSTEMK914396SURGI LIGHT NON-CONTACT FIBERS

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Related Devices (Code: HMW)

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.

K911040INVOTEC MICROSCOPE DRAPEInvotec International, Inc.K902763STERILE INSTRUMENT DRAPENorth American Sterilization & Packaging Co.K902851MICROSCOPE DRAPEMedical Technique Instruments, Inc.

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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