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FDA 510(k)

EXETER OPERATING LOUPE

K-Number: K863983 · 1986-11-10

ApplicantExeter Instruments, Inc.
Decision Date1986-11-10
Product CodeHJH
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EXETER OPERATING LOUPE is the device name listed in this FDA 510(k) record. The listed applicant is Exeter Instruments, Inc.. It received FDA 510(k) clearance on 1986-11-10 under 510(k) number K863983. The device is classified under product code HJH. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXETER OPERATING LOUPE?

EXETER OPERATING LOUPE is a medical device that received FDA 510(k) clearance on 1986-11-10. The listed applicant is Exeter Instruments, Inc.. The 510(k) number is K863983.

When did EXETER OPERATING LOUPE receive FDA 510(k) clearance?

EXETER OPERATING LOUPE received FDA 510(k) clearance on 1986-11-10, under 510(k) number K863983.

Who is the listed applicant for EXETER OPERATING LOUPE?

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

What is the FDA product code for EXETER OPERATING LOUPE?

The FDA product code for EXETER OPERATING LOUPE is HJH.

Related Clinical Trials

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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Other records listing Exeter Instruments, 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.

K810817EXETER OPERATING LOUPE

Related Devices (Code: HJH)

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.

K874845MALIS SURGICAL LOUPESValley Forge Scientific Corp.K830878BINOCULAR LOUPEAlmore Intl., Inc.

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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