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FDA 510(k)

EYE GARD

K-Number: K872000 · 1987-07-21

ApplicantTreace Medical, Inc.
Decision Date1987-07-21
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EYE GARD 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 1987-07-21 under 510(k) number K872000. The device is classified under product code HOY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EYE GARD?

EYE GARD is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Treace Medical, Inc.. The 510(k) number is K872000.

When did EYE GARD receive FDA 510(k) clearance?

EYE GARD received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872000.

Who is the listed applicant for EYE GARD?

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 EYE GARD?

The FDA product code for EYE GARD is HOY.

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 SYSTEMK870765CANNULATED INSTRUMENT CLEANERSK871706OPTHA PREP

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Related Devices (Code: HOY)

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.

K050856LCG (LIQUIDE CRYSTAL GLASSES) SYSTEMOphthocare , Ltd.K971465NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYSNational Healthcare Mfg. Corp.K944700ARCTIC PREMIER SERIESSungold Eyewear, Inc.K944857GOGGLE SAFEGUARDSellstrom Mfg. Co.K945351SHIELD, EYE, OPHTHALMICTaiwan Eva Industrial Co., Inc.K945346MAKROLON 2405 GOGGLES (LIGHT AND DARK)Universal Massage & Tanning, 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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