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FDA 510(k)

SURGICAL LOUPES

K-Number: K891895 · 1989-04-12

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1989-04-12
Product CodeFSP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL LOUPES is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1989-04-12 under 510(k) number K891895. The device is classified under product code FSP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL LOUPES?

SURGICAL LOUPES is a medical device that received FDA 510(k) clearance on 1989-04-12. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K891895.

When did SURGICAL LOUPES receive FDA 510(k) clearance?

SURGICAL LOUPES received FDA 510(k) clearance on 1989-04-12, under 510(k) number K891895.

Who is the listed applicant for SURGICAL LOUPES?

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

What is the FDA product code for SURGICAL LOUPES?

The FDA product code for SURGICAL LOUPES is FSP.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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Related Devices (Code: FSP)

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.

K895248IMS5000 ILLUMINATED LOUPESLuxtec Corp.K864386LUXTEC LOUPES FOR SURGICAL VISIONLuxtec Corp.K8617493X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCEKeeler Instruments, Inc.

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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