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FDA 510(k)

LTM-LABAROSCOPIC SURGICAL MESH

K-Number: K121289 · 2012-08-03

ApplicantLifecell Corp.
Decision Date2012-08-03
Product CodeOXK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LTM-LABAROSCOPIC SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Lifecell Corp.. It received FDA 510(k) clearance on 2012-08-03 under 510(k) number K121289. The device is classified under product code OXK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LTM-LABAROSCOPIC SURGICAL MESH?

LTM-LABAROSCOPIC SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2012-08-03. The listed applicant is Lifecell Corp.. The 510(k) number is K121289.

When did LTM-LABAROSCOPIC SURGICAL MESH receive FDA 510(k) clearance?

LTM-LABAROSCOPIC SURGICAL MESH received FDA 510(k) clearance on 2012-08-03, under 510(k) number K121289.

Who is the listed applicant for LTM-LABAROSCOPIC SURGICAL MESH?

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

What is the FDA product code for LTM-LABAROSCOPIC SURGICAL MESH?

The FDA product code for LTM-LABAROSCOPIC SURGICAL MESH is OXK.

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Other records listing Lifecell Corp. 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.

K130817LTN - LAPAROSCOPIC SURGICAL MESHK112534LIFECELL TISSUE EXPANDERK082176LTM-BPS SURGICAL MESHK082103LTM WOUND DRESSINGK080353LTM-T SURGICAL MESHK071986LTM-RC SURGICAL MESH

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Related Devices (Code: OXK)

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.

K130817LTN - LAPAROSCOPIC SURGICAL MESHLifecell Corp.

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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