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FDA 510(k)

BIOSPLINT SPLINTING RIBBON

K-Number: K053328 · 2006-01-25

ApplicantSatelec
Decision Date2006-01-25
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOSPLINT SPLINTING RIBBON is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2006-01-25 under 510(k) number K053328. 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 BIOSPLINT SPLINTING RIBBON?

BIOSPLINT SPLINTING RIBBON is a medical device that received FDA 510(k) clearance on 2006-01-25. The listed applicant is Satelec. The 510(k) number is K053328.

When did BIOSPLINT SPLINTING RIBBON receive FDA 510(k) clearance?

BIOSPLINT SPLINTING RIBBON received FDA 510(k) clearance on 2006-01-25, under 510(k) number K053328.

Who is the listed applicant for BIOSPLINT SPLINTING RIBBON?

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

What is the FDA product code for BIOSPLINT SPLINTING RIBBON?

The FDA product code for BIOSPLINT SPLINTING RIBBON is EBI.

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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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