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FDA 510(k)

OPHTHALMIC MICROSCOPE

K-Number: K822563 · 1982-09-14

ApplicantTreace Medical, Inc.
Decision Date1982-09-14
Product CodeHRM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC MICROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical, Inc.. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822563. The device is classified under product code HRM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMIC MICROSCOPE?

OPHTHALMIC MICROSCOPE is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Treace Medical, Inc.. The 510(k) number is K822563.

When did OPHTHALMIC MICROSCOPE receive FDA 510(k) clearance?

OPHTHALMIC MICROSCOPE received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822563.

Who is the listed applicant for OPHTHALMIC MICROSCOPE?

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

What is the FDA product code for OPHTHALMIC MICROSCOPE?

The FDA product code for OPHTHALMIC MICROSCOPE is HRM.

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Other records listing Treace Medical, 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.

K883727BUCKET PROSTHESIS PORPK882349MALLET, SURGICALK874779BIPOLATOR 50K873154TREACE MAGNUM OTO-TOOL SYSTEMK872000EYE GARDK870765CANNULATED INSTRUMENT CLEANERS

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Related Devices (Code: HRM)

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.

K932720HM-0970Hill-Med, Inc.K930439MARCO SURGISCOPE OPERATION MICROSCOPESMarco Ophthalmic, Inc.K920641ALCON OPERATING MICROSCOPESAlcon LaboratoriesK914956KEELER KONAN SPECULAR MICROSCOPE SP5500Keeler Instruments, Inc.K891584S 22 INSTRUMENT STANDCarl Zeiss, Inc.K891001MICROSCOPE KNOB COVER, STERILE, DISPOSABLEPrescott'S, 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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