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FDA 510(k)

ebb Complete Tamponade System

K-Number: K153591 · 2016-01-14

ApplicantClinical Innovations, LLC
Decision Date2016-01-14
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ebb Complete Tamponade System is a medical device manufactured by Clinical Innovations, LLC. It received FDA 510(k) clearance on 2016-01-14 under approval number K153591. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ebb Complete Tamponade System?

ebb Complete Tamponade System is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Clinical Innovations, LLC. The 510(k) number is K153591.

When was ebb Complete Tamponade System approved by the FDA?

ebb Complete Tamponade System received FDA 510(k) clearance on 2016-01-14, under approval number K153591.

What company makes ebb Complete Tamponade System?

ebb Complete Tamponade System is manufactured by Clinical Innovations, LLC.

What is the FDA product code for ebb Complete Tamponade System?

The FDA product code for ebb Complete Tamponade System is OQY.

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Related Devices (Code: OQY)

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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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