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FDA 510(k)

BIOINTEGRATOR, BIOINTEGRATOR PLUS

K-Number: K942769 · 1995-09-01

ApplicantBio Research Institute
Decision Date1995-09-01
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIOINTEGRATOR, BIOINTEGRATOR PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Bio Research Institute. It received FDA 510(k) clearance on 1995-09-01 under 510(k) number K942769. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOINTEGRATOR, BIOINTEGRATOR PLUS?

BIOINTEGRATOR, BIOINTEGRATOR PLUS is a medical device that received FDA 510(k) clearance on 1995-09-01. The listed applicant is Bio Research Institute. The 510(k) number is K942769.

When did BIOINTEGRATOR, BIOINTEGRATOR PLUS receive FDA 510(k) clearance?

BIOINTEGRATOR, BIOINTEGRATOR PLUS received FDA 510(k) clearance on 1995-09-01, under 510(k) number K942769.

Who is the listed applicant for BIOINTEGRATOR, BIOINTEGRATOR PLUS?

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

What is the FDA product code for BIOINTEGRATOR, BIOINTEGRATOR PLUS?

The FDA product code for BIOINTEGRATOR, BIOINTEGRATOR PLUS is HCC.

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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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