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FDA 510(k)

Mould Applicator Set

K-Number: K162615 · 2017-03-24

ApplicantVarian Medical Systems, Inc.
Decision Date2017-03-24
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Mould Applicator Set is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2017-03-24 under approval number K162615. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mould Applicator Set?

Mould Applicator Set is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K162615.

When was Mould Applicator Set approved by the FDA?

Mould Applicator Set received FDA 510(k) clearance on 2017-03-24, under approval number K162615.

What company makes Mould Applicator Set?

Mould Applicator Set is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for Mould Applicator Set?

The FDA product code for Mould Applicator Set is JAQ.

Other Devices by Varian Medical Systems, Inc.

K162476Varian High Energy Linear Accelerator K160045Heyman Packing Applicator Set K161540Advanced Breast Template System K161576Esophagus Bougie Set K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths K160021Varian Sterilization Boxes

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Related Devices (Code: JAQ)

K160045Heyman Packing Applicator SetVarian Medical Systems, Inc. K161540Advanced Breast Template SystemVarian Medical Systems, Inc. K161576Esophagus Bougie SetVarian Medical Systems, Inc. K160516Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengthsVarian Medical Systems, Inc. K150979CT/MR Compatible M.A.C. Interstitial GYN TemplateMick Radio-Nuclear Instruments, Inc. K160021Varian Sterilization BoxesVarian Medical Systems, Inc.

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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