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FDA 510(k)

SHILEY LOW PRESSURE THIN-CUFFED TRACH.

K-Number: K792222 · 1979-12-18

ApplicantShiley, Inc.
Decision Date1979-12-18
Product CodeEQN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SHILEY LOW PRESSURE THIN-CUFFED TRACH. is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1979-12-18 under 510(k) number K792222. 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 LOW PRESSURE THIN-CUFFED TRACH.?

SHILEY LOW PRESSURE THIN-CUFFED TRACH. is a medical device that received FDA 510(k) clearance on 1979-12-18. The listed applicant is Shiley, Inc.. The 510(k) number is K792222.

When did SHILEY LOW PRESSURE THIN-CUFFED TRACH. receive FDA 510(k) clearance?

SHILEY LOW PRESSURE THIN-CUFFED TRACH. received FDA 510(k) clearance on 1979-12-18, under 510(k) number K792222.

Who is the listed applicant for SHILEY LOW PRESSURE THIN-CUFFED TRACH.?

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 LOW PRESSURE THIN-CUFFED TRACH.?

The FDA product code for SHILEY LOW PRESSURE THIN-CUFFED TRACH. is EQN.

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Other records listing Shiley, Inc. as applicant

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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)

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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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