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FDA 510(k)

INVOTEC SEPTAL BUTTON

K-Number: K901366 · 1990-06-14

ApplicantInvotec International, Inc.
Decision Date1990-06-14
Product CodeLFB
DecisionSubstantially Equivalent

Device Summary

INVOTEC SEPTAL BUTTON is the device name listed in this FDA 510(k) record. The listed applicant is Invotec International, Inc.. It received FDA 510(k) clearance on 1990-06-14 under 510(k) number K901366. The device is classified under product code LFB. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INVOTEC SEPTAL BUTTON?

INVOTEC SEPTAL BUTTON is a medical device that received FDA 510(k) clearance on 1990-06-14. The listed applicant is Invotec International, Inc.. The 510(k) number is K901366.

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

INVOTEC SEPTAL BUTTON received FDA 510(k) clearance on 1990-06-14, under 510(k) number K901366.

Who is the listed applicant for INVOTEC SEPTAL BUTTON?

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

What is the FDA product code for INVOTEC SEPTAL BUTTON?

The FDA product code for INVOTEC SEPTAL BUTTON is LFB.

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Other records listing Invotec International, 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.

K122040INVOTEC LARYNGEAL ELECTRODEK080740CLEARVIEW ENDOSCOPE COVERK030492TITANIUM OSSICULAR REPLACMENT SYSTEMK973580INVOTEC CLEAN PADK973578INVOTEC EAR TAMPON (WICK) W/STRINGK971000EPISTAXIS NASAL PACK

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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, LLCK013696SILMED NASAL SEPTAL BUTTONSilmed, Inc.K982667MICROMEDICS NASAL SEPTAL BUTTONMicromedics, Inc.K972060NASAL SEPTAL BUTTONBoston Medical Products, Inc.K920994HOOD NASAL SEPTAL BUTTONHood LaboratoriesK871072OMEGA NASAL SEPTAL BUTTONOmega Silicone, 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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