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FDA 510(k)

STRAPPED EYE SHIELD

K-Number: K896172 · 1989-11-03

ApplicantEye Garter Company, Inc.
Decision Date1989-11-03
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STRAPPED 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 1989-11-03 under 510(k) number K896172. 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 STRAPPED EYE SHIELD?

STRAPPED EYE SHIELD is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Eye Garter Company, Inc.. The 510(k) number is K896172.

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

STRAPPED EYE SHIELD received FDA 510(k) clearance on 1989-11-03, under 510(k) number K896172.

Who is the listed applicant for STRAPPED 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 STRAPPED EYE SHIELD?

The FDA product code for STRAPPED 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.

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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 PATCHK880489CLEAR EYE GARTER SHIELDK880490BLUE PLASTIC EYE 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

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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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