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FDA 510(k)

ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES

K-Number: K954965 · 1995-12-18

ApplicantZomed Intl.
Decision Date1995-12-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES is the device name listed in this FDA 510(k) record. The listed applicant is Zomed Intl.. It received FDA 510(k) clearance on 1995-12-18 under 510(k) number K954965. 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 ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES?

ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES is a medical device that received FDA 510(k) clearance on 1995-12-18. The listed applicant is Zomed Intl.. The 510(k) number is K954965.

When did ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES receive FDA 510(k) clearance?

ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES received FDA 510(k) clearance on 1995-12-18, under 510(k) number K954965.

Who is the listed applicant for ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES?

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

What is the FDA product code for ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES?

The FDA product code for ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES is GEI.

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Other records listing Zomed Intl. as applicant

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.

K964286ZOMED PASSIVE TEMPERATURE PROBEK962692ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBEK960695MODEL 200C ELECTROSURGICAL PROBEK960694ZOMED 30F ELECTROSURGICAL PROBEK952072ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBEK951659ZOMED MODEL 10 CAUTERY BIOPSY DEVICE

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Related Devices (Code: GEI)

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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