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FDA 510(k)

SURGIN EYE SHIELD

K-Number: K881232 · 1988-04-13

ApplicantSurgeon Surgical Instrumentation, Inc.
Decision Date1988-04-13
Product CodeHOY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURGIN EYE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Surgeon Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K881232. 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 SURGIN EYE SHIELD?

SURGIN EYE SHIELD is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Surgeon Surgical Instrumentation, Inc.. The 510(k) number is K881232.

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

SURGIN EYE SHIELD received FDA 510(k) clearance on 1988-04-13, under 510(k) number K881232.

Who is the listed applicant for SURGIN EYE SHIELD?

The FDA 510(k) record lists Surgeon Surgical Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIN EYE SHIELD?

The FDA product code for SURGIN EYE SHIELD is HOY.

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Other records listing Surgeon Surgical Instrumentation, 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.

K954241SURGIN GENISIS PHACOEMULSIFIERK932281VERRES NEEDLEK922038CO2 INSUFFLATION TUBINGK904010SURGICAL ASPIRATOR KITK890447HEMORRHAGE OCCLUDORK880543UNI-PORT

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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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