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FDA 510(k)

EASY CONTROL MICRO INSERTER, MODEL ON385

K-Number: K011498 · 2001-07-09

ApplicantOphtec USA, Inc.
Decision Date2001-07-09
Product CodeNCE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EASY CONTROL MICRO INSERTER, MODEL ON385 is the device name listed in this FDA 510(k) record. The listed applicant is Ophtec USA, Inc.. It received FDA 510(k) clearance on 2001-07-09 under 510(k) number K011498. The device is classified under product code NCE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY CONTROL MICRO INSERTER, MODEL ON385?

EASY CONTROL MICRO INSERTER, MODEL ON385 is a medical device that received FDA 510(k) clearance on 2001-07-09. The listed applicant is Ophtec USA, Inc.. The 510(k) number is K011498.

When did EASY CONTROL MICRO INSERTER, MODEL ON385 receive FDA 510(k) clearance?

EASY CONTROL MICRO INSERTER, MODEL ON385 received FDA 510(k) clearance on 2001-07-09, under 510(k) number K011498.

Who is the listed applicant for EASY CONTROL MICRO INSERTER, MODEL ON385?

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

What is the FDA product code for EASY CONTROL MICRO INSERTER, MODEL ON385?

The FDA product code for EASY CONTROL MICRO INSERTER, MODEL ON385 is NCE.

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Related Devices (Code: NCE)

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.

K042478CAPSULE TENSION RING INSERTER, MODEL 7-810Duckworth & Kent, Ltd.K001125GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RINGGeuder GmbH

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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