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FDA 510(k)

ONE-WAY VALVE (WITH CONNECTOR)

K-Number: K970780 · 1997-09-18

ApplicantInstrumentation Industries, Inc.
Decision Date1997-09-18
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ONE-WAY VALVE (WITH CONNECTOR) is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Industries, Inc.. It received FDA 510(k) clearance on 1997-09-18 under 510(k) number K970780. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONE-WAY VALVE (WITH CONNECTOR)?

ONE-WAY VALVE (WITH CONNECTOR) is a medical device that received FDA 510(k) clearance on 1997-09-18. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K970780.

When did ONE-WAY VALVE (WITH CONNECTOR) receive FDA 510(k) clearance?

ONE-WAY VALVE (WITH CONNECTOR) received FDA 510(k) clearance on 1997-09-18, under 510(k) number K970780.

Who is the listed applicant for ONE-WAY VALVE (WITH CONNECTOR)?

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

What is the FDA product code for ONE-WAY VALVE (WITH CONNECTOR)?

The FDA product code for ONE-WAY VALVE (WITH CONNECTOR) is CBP.

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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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