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FDA 510(k)

BLUE PLASTIC EYE SHIELD

K-Number: K880490 · 1988-05-03

ApplicantEye Garter Company, Inc.
Decision Date1988-05-03
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLUE PLASTIC EYE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Eye Garter Company, Inc.. It received FDA 510(k) clearance on 1988-05-03 under 510(k) number K880490. 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 BLUE PLASTIC EYE SHIELD?

BLUE PLASTIC EYE SHIELD is a medical device that received FDA 510(k) clearance on 1988-05-03. The listed applicant is Eye Garter Company, Inc.. The 510(k) number is K880490.

When did BLUE PLASTIC EYE SHIELD receive FDA 510(k) clearance?

BLUE PLASTIC EYE SHIELD received FDA 510(k) clearance on 1988-05-03, under 510(k) number K880490.

Who is the listed applicant for BLUE PLASTIC EYE SHIELD?

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

What is the FDA product code for BLUE PLASTIC EYE SHIELD?

The FDA product code for BLUE PLASTIC EYE SHIELD is HOY.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Eye Garter Company, 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.

K900941OMNIPATCHK896171EYE PATCHK896172STRAPPED EYE SHIELDK880489CLEAR EYE GARTER SHIELDK880675EASY SHIELD ADHESIVE BANDAGE

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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