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FDA 510(k)

DISPOSABLE THYROID COLLAR

K-Number: K110900 · 2011-06-24

ApplicantBloxr Corporation
Decision Date2011-06-24
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE THYROID COLLAR is the device name listed in this FDA 510(k) record. The listed applicant is Bloxr Corporation. It received FDA 510(k) clearance on 2011-06-24 under 510(k) number K110900. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE THYROID COLLAR?

DISPOSABLE THYROID COLLAR is a medical device that received FDA 510(k) clearance on 2011-06-24. The listed applicant is Bloxr Corporation. The 510(k) number is K110900.

When did DISPOSABLE THYROID COLLAR receive FDA 510(k) clearance?

DISPOSABLE THYROID COLLAR received FDA 510(k) clearance on 2011-06-24, under 510(k) number K110900.

Who is the listed applicant for DISPOSABLE THYROID COLLAR?

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

What is the FDA product code for DISPOSABLE THYROID COLLAR?

The FDA product code for DISPOSABLE THYROID COLLAR is KPY.

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Related Devices (Code: KPY)

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.

K962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.K951003KENEX RADIATION SHIELD (VARIOUS MODELS AS EXHIBITS #2 & 5)Kenex , Ltd.

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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