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FDA 510(k)

FIRST SPEP

K-Number: K012032 · 2001-09-17

ApplicantBisco, Inc.
Decision Date2001-09-17
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIRST SPEP is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2001-09-17 under 510(k) number K012032. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST SPEP?

FIRST SPEP is a medical device that received FDA 510(k) clearance on 2001-09-17. The listed applicant is Bisco, Inc.. The 510(k) number is K012032.

When did FIRST SPEP receive FDA 510(k) clearance?

FIRST SPEP received FDA 510(k) clearance on 2001-09-17, under 510(k) number K012032.

Who is the listed applicant for FIRST SPEP?

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 FIRST SPEP?

The FDA product code for FIRST SPEP is DYH.

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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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