FDA 510(k)

MODEL GV-10 LANZ PRESSURE-VALVE

K-Number: K791045 · 1979-06-13

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1979-06-13

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MODEL GV-10 LANZ PRESSURE-VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1979-06-13 under 510(k) number K791045. 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 MODEL GV-10 LANZ PRESSURE-VALVE?

MODEL GV-10 LANZ PRESSURE-VALVE is a medical device that received FDA 510(k) clearance on 1979-06-13. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K791045.

When did MODEL GV-10 LANZ PRESSURE-VALVE receive FDA 510(k) clearance?

MODEL GV-10 LANZ PRESSURE-VALVE received FDA 510(k) clearance on 1979-06-13, under 510(k) number K791045.

Who is the listed applicant for MODEL GV-10 LANZ PRESSURE-VALVE?

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

What is the FDA product code for MODEL GV-10 LANZ PRESSURE-VALVE?

The FDA product code for MODEL GV-10 LANZ PRESSURE-VALVE is BTR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.