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FDA 510(k)

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR

K-Number: K063442 · 2007-03-26

ApplicantDegania Silicone , Ltd.
Decision Date2007-03-26
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Degania Silicone , Ltd.. It received FDA 510(k) clearance on 2007-03-26 under 510(k) number K063442. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR?

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR is a medical device that received FDA 510(k) clearance on 2007-03-26. The listed applicant is Degania Silicone , Ltd.. The 510(k) number is K063442.

When did ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR receive FDA 510(k) clearance?

ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR received FDA 510(k) clearance on 2007-03-26, under 510(k) number K063442.

Who is the listed applicant for ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR?

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

What is the FDA product code for ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR?

The FDA product code for ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR is EZL.

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Related Devices (Code: EZL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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