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FDA 510(k)

SAFE-EDGE EYESHIELD

K-Number: K894724 · 1989-09-14

ApplicantTrident Medical Products, Inc.
Decision Date1989-09-14
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SAFE-EDGE EYESHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Trident Medical Products, Inc.. It received FDA 510(k) clearance on 1989-09-14 under 510(k) number K894724. 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 SAFE-EDGE EYESHIELD?

SAFE-EDGE EYESHIELD is a medical device that received FDA 510(k) clearance on 1989-09-14. The listed applicant is Trident Medical Products, Inc.. The 510(k) number is K894724.

When did SAFE-EDGE EYESHIELD receive FDA 510(k) clearance?

SAFE-EDGE EYESHIELD received FDA 510(k) clearance on 1989-09-14, under 510(k) number K894724.

Who is the listed applicant for SAFE-EDGE EYESHIELD?

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

What is the FDA product code for SAFE-EDGE EYESHIELD?

The FDA product code for SAFE-EDGE EYESHIELD 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 Trident Medical Products, 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.

K895011TRIDENT DRAPE SUPPORTK894720UNIVERSAL EYESHIELD

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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