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FDA 510(k)

PROcedure Rehearsal Studio

K-Number: K153705 · 2016-09-02

Applicant3Dsystems, Simbionix Products
Decision Date2016-09-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROcedure Rehearsal Studio is a medical device manufactured by 3Dsystems, Simbionix Products. It received FDA 510(k) clearance on 2016-09-02 under approval number K153705. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROcedure Rehearsal Studio?

PROcedure Rehearsal Studio is a medical device that received FDA 510(k) clearance on 2016-09-02. It is manufactured by 3Dsystems, Simbionix Products. The 510(k) number is K153705.

When was PROcedure Rehearsal Studio approved by the FDA?

PROcedure Rehearsal Studio received FDA 510(k) clearance on 2016-09-02, under approval number K153705.

What company makes PROcedure Rehearsal Studio?

PROcedure Rehearsal Studio is manufactured by 3Dsystems, Simbionix Products.

What is the FDA product code for PROcedure Rehearsal Studio?

The FDA product code for PROcedure Rehearsal Studio is LLZ.

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Official Source

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