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FDA 510(k)

TOPICAL APPLICATOR

K-Number: K070596 · 2007-06-21

ApplicantSharn, Inc.
Decision Date2007-06-21
Product CodeCCT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TOPICAL APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sharn, Inc.. It received FDA 510(k) clearance on 2007-06-21 under 510(k) number K070596. The device is classified under product code CCT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPICAL APPLICATOR?

TOPICAL APPLICATOR is a medical device that received FDA 510(k) clearance on 2007-06-21. The listed applicant is Sharn, Inc.. The 510(k) number is K070596.

When did TOPICAL APPLICATOR receive FDA 510(k) clearance?

TOPICAL APPLICATOR received FDA 510(k) clearance on 2007-06-21, under 510(k) number K070596.

Who is the listed applicant for TOPICAL APPLICATOR?

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

What is the FDA product code for TOPICAL APPLICATOR?

The FDA product code for TOPICAL APPLICATOR is CCT.

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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Other records listing Sharn, 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.

K932305VILA-COOKE(TM) ANESTHESIA PILLOWK894032EVAC-TUBEK860558ESOPHAGEAL STETHOSCOPE

Related Devices (Code: CCT)

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.

K240114UltraEzAir® (UEA1A)Dualams, Inc., Dba AirkorK172956Medicant Mucosal AtomizerMedica Holdings, LLCK153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex MedicalK093584EZ-MISTERN.M. Beale Co., Inc.K002255LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)Wolfe Tory Medical, Inc.K894755ASTRA DISPOSABLE SPRAY CANNULAAstra Pharmaceutical Products, 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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