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FDA 510(k)

MENDEZ U/S CYSTOTOME

K-Number: K843386 · 1984-11-27

ApplicantCooperVision, Inc.
Decision Date1984-11-27
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MENDEZ U/S CYSTOTOME is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1984-11-27 under 510(k) number K843386. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENDEZ U/S CYSTOTOME?

MENDEZ U/S CYSTOTOME is a medical device that received FDA 510(k) clearance on 1984-11-27. The listed applicant is CooperVision, Inc.. The 510(k) number is K843386.

When did MENDEZ U/S CYSTOTOME receive FDA 510(k) clearance?

MENDEZ U/S CYSTOTOME received FDA 510(k) clearance on 1984-11-27, under 510(k) number K843386.

Who is the listed applicant for MENDEZ U/S CYSTOTOME?

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

What is the FDA product code for MENDEZ U/S CYSTOTOME?

The FDA product code for MENDEZ U/S CYSTOTOME is HQC.

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Related Devices (Code: HQC)

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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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