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FDA 510(k)

ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES

K-Number: K051509 · 2005-07-27

ApplicantErbe USA, Inc.
Decision Date2005-07-27
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Erbe USA, Inc.. It received FDA 510(k) clearance on 2005-07-27 under 510(k) number K051509. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES?

ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES is a medical device that received FDA 510(k) clearance on 2005-07-27. The listed applicant is Erbe USA, Inc.. The 510(k) number is K051509.

When did ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES receive FDA 510(k) clearance?

ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES received FDA 510(k) clearance on 2005-07-27, under 510(k) number K051509.

Who is the listed applicant for ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES?

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

What is the FDA product code for ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES?

The FDA product code for ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES is GEH.

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Related Devices (Code: GEH)

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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