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FDA 510(k)

LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM

K-Number: K080158 · 2008-05-02

ApplicantLb Medical LLC
Decision Date2008-05-02
Product CodeFZW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lb Medical LLC. It received FDA 510(k) clearance on 2008-05-02 under 510(k) number K080158. The device is classified under product code FZW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM?

LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-02. The listed applicant is Lb Medical LLC. The 510(k) number is K080158.

When did LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM receive FDA 510(k) clearance?

LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM received FDA 510(k) clearance on 2008-05-02, under 510(k) number K080158.

Who is the listed applicant for LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM?

The FDA 510(k) record lists Lb Medical LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM?

The FDA product code for LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM is FZW.

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Related Devices (Code: FZW)

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.

K984448BIRCOLL BALLOON DISSECTORWells Johnson Co.K972109SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDERGeneral Surgical InnovationsK936186AESCULAP SKIN GRAFT MESHERAesculap, Inc.K904265INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDERInamed Development Co.K902349SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDERSurgitekK883303MENTOR RAPID-SPAN (TM) TISSUE EXPANDERMentor Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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