FDA 510(k)

SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL

K-Number: K821027 · 1982-05-03

Decision Date1982-05-03

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1982-05-03 under 510(k) number K821027. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL?

SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Shiley, Inc.. The 510(k) number is K821027.

When did SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL receive FDA 510(k) clearance?

SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL received FDA 510(k) clearance on 1982-05-03, under 510(k) number K821027.

Who is the listed applicant for SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL?

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 SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL?

The FDA product code for SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL is BTR.

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Related Devices (Code: BTR)

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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.