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FDA 510(k)

ANNULOFLO SYSTEM

K-Number: K970375 · 1997-07-25

ApplicantCarbomedics, Inc.
Decision Date1997-07-25
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

ANNULOFLO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1997-07-25 under 510(k) number K970375. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the ANNULOFLO SYSTEM?

ANNULOFLO SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-25. The listed applicant is Carbomedics, Inc.. The 510(k) number is K970375.

When did ANNULOFLO SYSTEM receive FDA 510(k) clearance?

ANNULOFLO SYSTEM received FDA 510(k) clearance on 1997-07-25, under 510(k) number K970375.

Who is the listed applicant for ANNULOFLO SYSTEM?

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

What is the FDA product code for ANNULOFLO SYSTEM?

The FDA product code for ANNULOFLO SYSTEM is KRH.

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Related Devices (Code: KRH)

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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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