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FDA 510(k)

SERIES TEN THOUSAND MASTER

K-Number: K861380 · 1986-07-11

ApplicantCooperVision, Inc.
Decision Date1986-07-11
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SERIES TEN THOUSAND MASTER is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K861380. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES TEN THOUSAND MASTER?

SERIES TEN THOUSAND MASTER is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is CooperVision, Inc.. The 510(k) number is K861380.

When did SERIES TEN THOUSAND MASTER receive FDA 510(k) clearance?

SERIES TEN THOUSAND MASTER received FDA 510(k) clearance on 1986-07-11, under 510(k) number K861380.

Who is the listed applicant for SERIES TEN THOUSAND MASTER?

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 SERIES TEN THOUSAND MASTER?

The FDA product code for SERIES TEN THOUSAND MASTER is HQE.

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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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