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FDA 510(k)

I-SPOSE EYE SHIELD

K-Number: K883658 · 1988-10-25

ApplicantProducts For Medicine
Decision Date1988-10-25
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I-SPOSE EYE SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Products For Medicine. It received FDA 510(k) clearance on 1988-10-25 under 510(k) number K883658. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-SPOSE EYE SHIELD?

I-SPOSE EYE SHIELD is a medical device that received FDA 510(k) clearance on 1988-10-25. The listed applicant is Products For Medicine. The 510(k) number is K883658.

When did I-SPOSE EYE SHIELD receive FDA 510(k) clearance?

I-SPOSE EYE SHIELD received FDA 510(k) clearance on 1988-10-25, under 510(k) number K883658.

Who is the listed applicant for I-SPOSE EYE SHIELD?

The FDA 510(k) record lists Products For Medicine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-SPOSE EYE SHIELD?

The FDA product code for I-SPOSE EYE SHIELD is FXX.

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Other records listing Products For Medicine 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.

K963227WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175K955510X6000D SILENT SUN LIGHT SOURCEK953089I-SPOUSEK951704NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATIONK951703TAMPER EVIDENT ARROWS WITH AND WITHOUT STERILIZATION INDICATORS

Related Devices (Code: FXX)

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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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