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FDA 510(k)

SHILEY LARYNGECTOMY TUBE

K-Number: K821993 · 1982-08-12

ApplicantShiley, Inc.
Decision Date1982-08-12
Product CodeKAC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SHILEY LARYNGECTOMY 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 1982-08-12 under 510(k) number K821993. The device is classified under product code KAC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHILEY LARYNGECTOMY TUBE?

SHILEY LARYNGECTOMY TUBE is a medical device that received FDA 510(k) clearance on 1982-08-12. The listed applicant is Shiley, Inc.. The 510(k) number is K821993.

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

SHILEY LARYNGECTOMY TUBE received FDA 510(k) clearance on 1982-08-12, under 510(k) number K821993.

Who is the listed applicant for SHILEY LARYNGECTOMY 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 LARYNGECTOMY TUBE?

The FDA product code for SHILEY LARYNGECTOMY TUBE is KAC.

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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: KAC)

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.

K901377BARTON-MAYO TRACHEOSTOMA BUTTONMedical Innovations International, Inc.K873992LARYNGECTOMY TUBEPortex, Inc.K811428NORTHWESTERN VOICE RESTORATION KITUniversal Prosthetics, 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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