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FDA 510(k)

COSMAN COAGULATOR (CC-1) SYSTEM

K-Number: K973297 · 1997-10-29

ApplicantRadionics, Inc.
Decision Date1997-10-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COSMAN COAGULATOR (CC-1) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1997-10-29 under 510(k) number K973297. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMAN COAGULATOR (CC-1) SYSTEM?

COSMAN COAGULATOR (CC-1) SYSTEM is a medical device that received FDA 510(k) clearance on 1997-10-29. The listed applicant is Radionics, Inc.. The 510(k) number is K973297.

When did COSMAN COAGULATOR (CC-1) SYSTEM receive FDA 510(k) clearance?

COSMAN COAGULATOR (CC-1) SYSTEM received FDA 510(k) clearance on 1997-10-29, under 510(k) number K973297.

Who is the listed applicant for COSMAN COAGULATOR (CC-1) SYSTEM?

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

What is the FDA product code for COSMAN COAGULATOR (CC-1) SYSTEM?

The FDA product code for COSMAN COAGULATOR (CC-1) SYSTEM is GEI.

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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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