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FDA 510(k)

RENEW LS-1

K-Number: K003317 · 2000-11-21

ApplicantBisco, Inc.
Decision Date2000-11-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RENEW LS-1 is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2000-11-21 under 510(k) number K003317. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENEW LS-1?

RENEW LS-1 is a medical device that received FDA 510(k) clearance on 2000-11-21. The listed applicant is Bisco, Inc.. The 510(k) number is K003317.

When did RENEW LS-1 receive FDA 510(k) clearance?

RENEW LS-1 received FDA 510(k) clearance on 2000-11-21, under 510(k) number K003317.

Who is the listed applicant for RENEW LS-1?

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 RENEW LS-1?

The FDA product code for RENEW LS-1 is EBF.

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Other records listing Bisco, Inc. as applicant

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Related Devices (Code: EBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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