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FDA 510(k)

LAL TEST RELEASE & BONCHEK CAR/JACKET

K-Number: K833555 · 1984-02-04

ApplicantShiley, Inc.
Decision Date1984-02-04
Product CodeDTR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LAL TEST RELEASE & BONCHEK CAR/JACKET is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K833555. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAL TEST RELEASE & BONCHEK CAR/JACKET?

LAL TEST RELEASE & BONCHEK CAR/JACKET is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Shiley, Inc.. The 510(k) number is K833555.

When did LAL TEST RELEASE & BONCHEK CAR/JACKET receive FDA 510(k) clearance?

LAL TEST RELEASE & BONCHEK CAR/JACKET received FDA 510(k) clearance on 1984-02-04, under 510(k) number K833555.

Who is the listed applicant for LAL TEST RELEASE & BONCHEK CAR/JACKET?

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 LAL TEST RELEASE & BONCHEK CAR/JACKET?

The FDA product code for LAL TEST RELEASE & BONCHEK CAR/JACKET is DTR.

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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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