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FDA 510(k)

FIBER-SPLINT ML MULTILAYER

K-Number: K962374 · 1996-07-22

ApplicantPolydentia USA
Decision Date1996-07-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIBER-SPLINT ML MULTILAYER is the device name listed in this FDA 510(k) record. The listed applicant is Polydentia USA. It received FDA 510(k) clearance on 1996-07-22 under 510(k) number K962374. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBER-SPLINT ML MULTILAYER?

FIBER-SPLINT ML MULTILAYER is a medical device that received FDA 510(k) clearance on 1996-07-22. The listed applicant is Polydentia USA. The 510(k) number is K962374.

When did FIBER-SPLINT ML MULTILAYER receive FDA 510(k) clearance?

FIBER-SPLINT ML MULTILAYER received FDA 510(k) clearance on 1996-07-22, under 510(k) number K962374.

Who is the listed applicant for FIBER-SPLINT ML MULTILAYER?

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

What is the FDA product code for FIBER-SPLINT ML MULTILAYER?

The FDA product code for FIBER-SPLINT ML MULTILAYER is EBI.

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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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