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FDA 510(k)

BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR

K-Number: K042100 · 2004-09-20

ApplicantBlackstone Medical, Inc.
Decision Date2004-09-20
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Blackstone Medical, Inc.. It received FDA 510(k) clearance on 2004-09-20 under 510(k) number K042100. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR?

BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR is a medical device that received FDA 510(k) clearance on 2004-09-20. The listed applicant is Blackstone Medical, Inc.. The 510(k) number is K042100.

When did BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR receive FDA 510(k) clearance?

BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR received FDA 510(k) clearance on 2004-09-20, under 510(k) number K042100.

Who is the listed applicant for BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR?

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

What is the FDA product code for BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR?

The FDA product code for BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3.0MM SINGLE AXIAL CONNECTOR is MNI.

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Related Devices (Code: MNI)

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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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