FDA 510(k)

ACCU-PREP

K-Number: K970484 · 1997-07-01

Decision Date1997-07-01

Product CodeKOJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ACCU-PREP is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1997-07-01 under 510(k) number K970484. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-PREP?

ACCU-PREP is a medical device that received FDA 510(k) clearance on 1997-07-01. The listed applicant is Bisco, Inc.. The 510(k) number is K970484.

When did ACCU-PREP receive FDA 510(k) clearance?

ACCU-PREP received FDA 510(k) clearance on 1997-07-01, under 510(k) number K970484.

Who is the listed applicant for ACCU-PREP?

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

What is the FDA product code for ACCU-PREP?

The FDA product code for ACCU-PREP is KOJ.

Other records listing Bisco, Inc. as applicant

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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.