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FDA 510(k)

SILMED NASAL SEPTAL BUTTON

K-Number: K013696 · 2001-11-28

ApplicantSilmed, Inc.
Decision Date2001-11-28
Product CodeLFB
DecisionSubstantially Equivalent

Device Summary

SILMED NASAL SEPTAL BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Silmed, Inc.. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K013696. The device is classified under product code LFB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILMED NASAL SEPTAL BUTTON?

SILMED NASAL SEPTAL BUTTON is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is Silmed, Inc.. The 510(k) number is K013696.

When did SILMED NASAL SEPTAL BUTTON receive FDA 510(k) clearance?

SILMED NASAL SEPTAL BUTTON received FDA 510(k) clearance on 2001-11-28, under 510(k) number K013696.

Who is the listed applicant for SILMED NASAL SEPTAL BUTTON?

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

What is the FDA product code for SILMED NASAL SEPTAL BUTTON?

The FDA product code for SILMED NASAL SEPTAL BUTTON is LFB.

Related Clinical Trials

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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Related Devices (Code: LFB)

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.

K131745BLOM-SINGER SEPTAL PERFORATION PROSTHESISHelix Medical, LLCK982667MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.K972060NASAL SEPTAL BUTTONBoston Medical Products, Inc.K920994HOOD NASAL SEPTAL BUTTONHood LaboratoriesK901366INVOTEC SEPTAL BUTTONInvotec International, Inc.K871072OMEGA NASAL SEPTAL BUTTONOmega Silicone, Inc.

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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