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FDA 510(k)

SHILEY CRICOTHYROTOMY TUBE

K-Number: K781639 · 1978-10-24

ApplicantShiley, Inc.
Decision Date1978-10-24
Product CodeEQN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SHILEY CRICOTHYROTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1978-10-24 under 510(k) number K781639. The device is classified under product code EQN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY CRICOTHYROTOMY TUBE?

SHILEY CRICOTHYROTOMY TUBE is a medical device that received FDA 510(k) clearance on 1978-10-24. The listed applicant is Shiley, Inc.. The 510(k) number is K781639.

When did SHILEY CRICOTHYROTOMY TUBE receive FDA 510(k) clearance?

SHILEY CRICOTHYROTOMY TUBE received FDA 510(k) clearance on 1978-10-24, under 510(k) number K781639.

Who is the listed applicant for SHILEY CRICOTHYROTOMY TUBE?

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

What is the FDA product code for SHILEY CRICOTHYROTOMY TUBE?

The FDA product code for SHILEY CRICOTHYROTOMY TUBE is EQN.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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Related Devices (Code: EQN)

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.

K252624KARL STORZ Laryngoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc.K834172OP-CON SURG. INSTRUMENT #7Imm Enterprises , Ltd.K831255LARYNGOSCOPE ATTACHMENT PH2000Eder Instrument Co, Inc.K830888COOL-LITE FIBERCOPTIC LARYNGEAL EXAMNational Medical TechnologyK822525LARYNGOSCOPES RIGIDKelleher Corp.K821708NAGASHIMA LIGHT SOURCE UNIT SL-4Kelleher 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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