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FDA 510(k)

DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER

K-Number: K871068 · 1987-05-28

ApplicantLifestream Int'L, Inc.
Decision Date1987-05-28
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER 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 1987-05-28 under 510(k) number K871068. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER?

DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER is a medical device that received FDA 510(k) clearance on 1987-05-28. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K871068.

When did DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER receive FDA 510(k) clearance?

DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER received FDA 510(k) clearance on 1987-05-28, under 510(k) number K871068.

Who is the listed applicant for DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER?

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 DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER?

The FDA product code for DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER is KKX.

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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: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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