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FDA 510(k)

SHIELD, EYE, OPHTHALMIC

K-Number: K945351 · 1994-12-13

ApplicantTaiwan Eva Industrial Co., Inc.
Decision Date1994-12-13
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SHIELD, EYE, OPHTHALMIC is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Eva Industrial Co., Inc.. It received FDA 510(k) clearance on 1994-12-13 under 510(k) number K945351. 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 SHIELD, EYE, OPHTHALMIC?

SHIELD, EYE, OPHTHALMIC is a medical device that received FDA 510(k) clearance on 1994-12-13. The listed applicant is Taiwan Eva Industrial Co., Inc.. The 510(k) number is K945351.

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

SHIELD, EYE, OPHTHALMIC received FDA 510(k) clearance on 1994-12-13, under 510(k) number K945351.

Who is the listed applicant for SHIELD, EYE, OPHTHALMIC?

The FDA 510(k) record lists Taiwan Eva Industrial Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIELD, EYE, OPHTHALMIC?

The FDA product code for SHIELD, EYE, OPHTHALMIC 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 Taiwan Eva Industrial Co., 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.

K952438SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)K945350FRAME, SPECTACLES

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.K945346MAKROLON 2405 GOGGLES (LIGHT AND DARK)Universal Massage & Tanning, Inc.K942407AMCON SLIP IN MYDRIATIC SUNGLASSESAmcon Laboratories, 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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