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FDA 510(k)

BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD

K-Number: K080308 · 2008-04-14

ApplicantBioscaffold International Pte, Ltd.
Decision Date2008-04-14
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD is the device name listed in this FDA 510(k) record. The listed applicant is Bioscaffold International Pte, Ltd.. It received FDA 510(k) clearance on 2008-04-14 under 510(k) number K080308. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD?

BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD is a medical device that received FDA 510(k) clearance on 2008-04-14. The listed applicant is Bioscaffold International Pte, Ltd.. The 510(k) number is K080308.

When did BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD receive FDA 510(k) clearance?

BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD received FDA 510(k) clearance on 2008-04-14, under 510(k) number K080308.

Who is the listed applicant for BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD?

The FDA 510(k) record lists Bioscaffold International Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD?

The FDA product code for BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD is LYC.

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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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