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FDA 510(k)

HA, TP CYLINDER, UNIHOLE

K-Number: K953280 · 1995-09-15

ApplicantImplant Center of the Palm Beaches
Decision Date1995-09-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HA, TP CYLINDER, UNIHOLE is the device name listed in this FDA 510(k) record. The listed applicant is Implant Center of the Palm Beaches. It received FDA 510(k) clearance on 1995-09-15 under 510(k) number K953280. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HA, TP CYLINDER, UNIHOLE?

HA, TP CYLINDER, UNIHOLE is a medical device that received FDA 510(k) clearance on 1995-09-15. The listed applicant is Implant Center of the Palm Beaches. The 510(k) number is K953280.

When did HA, TP CYLINDER, UNIHOLE receive FDA 510(k) clearance?

HA, TP CYLINDER, UNIHOLE received FDA 510(k) clearance on 1995-09-15, under 510(k) number K953280.

Who is the listed applicant for HA, TP CYLINDER, UNIHOLE?

The FDA 510(k) record lists Implant Center of the Palm Beaches as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HA, TP CYLINDER, UNIHOLE?

The FDA product code for HA, TP CYLINDER, UNIHOLE is DZE.

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Other records listing Implant Center of the Palm Beaches as applicant

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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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