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FDA 510(k)

BIOSOFT RESIN

K-Number: K001640 · 2000-06-23

ApplicantBiosoft International Corp.
Decision Date2000-06-23
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOSOFT RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Biosoft International Corp.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K001640. 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 BIOSOFT RESIN?

BIOSOFT RESIN is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Biosoft International Corp.. The 510(k) number is K001640.

When did BIOSOFT RESIN receive FDA 510(k) clearance?

BIOSOFT RESIN received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001640.

Who is the listed applicant for BIOSOFT RESIN?

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

What is the FDA product code for BIOSOFT RESIN?

The FDA product code for BIOSOFT RESIN 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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