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FDA 510(k)

THERMOCOOL SYSTEM

K-Number: K950395 · 1995-08-18

ApplicantZimmer, Inc.
Decision Date1995-08-18
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

THERMOCOOL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1995-08-18 under 510(k) number K950395. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the THERMOCOOL SYSTEM?

THERMOCOOL SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-18. The listed applicant is Zimmer, Inc.. The 510(k) number is K950395.

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

THERMOCOOL SYSTEM received FDA 510(k) clearance on 1995-08-18, under 510(k) number K950395.

Who is the listed applicant for THERMOCOOL SYSTEM?

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

What is the FDA product code for THERMOCOOL SYSTEM?

The FDA product code for THERMOCOOL SYSTEM is ILO.

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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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