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FDA 510(k)

BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080

K-Number: K000544 · 2000-03-09

ApplicantLabtician Ophthalmics, Inc.
Decision Date2000-03-09
Product CodeHJX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 is the device name listed in this FDA 510(k) record. The listed applicant is Labtician Ophthalmics, Inc.. It received FDA 510(k) clearance on 2000-03-09 under 510(k) number K000544. The device is classified under product code HJX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080?

BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 is a medical device that received FDA 510(k) clearance on 2000-03-09. The listed applicant is Labtician Ophthalmics, Inc.. The 510(k) number is K000544.

When did BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 receive FDA 510(k) clearance?

BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 received FDA 510(k) clearance on 2000-03-09, under 510(k) number K000544.

Who is the listed applicant for BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080?

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

What is the FDA product code for BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080?

The FDA product code for BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 is HJX.

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Other records listing Labtician Ophthalmics, Inc. 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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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