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FDA 510(k)

REGEN COLLAGEN SCAFFOLD (CS)

K-Number: K082079 · 2008-12-18

ApplicantRegen Biologics, Inc.
Decision Date2008-12-18
Product CodeOLC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REGEN COLLAGEN SCAFFOLD (CS) is the device name listed in this FDA 510(k) record. The listed applicant is Regen Biologics, Inc.. It received FDA 510(k) clearance on 2008-12-18 under 510(k) number K082079. The device is classified under product code OLC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGEN COLLAGEN SCAFFOLD (CS)?

REGEN COLLAGEN SCAFFOLD (CS) is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Regen Biologics, Inc.. The 510(k) number is K082079.

When did REGEN COLLAGEN SCAFFOLD (CS) receive FDA 510(k) clearance?

REGEN COLLAGEN SCAFFOLD (CS) received FDA 510(k) clearance on 2008-12-18, under 510(k) number K082079.

Who is the listed applicant for REGEN COLLAGEN SCAFFOLD (CS)?

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

What is the FDA product code for REGEN COLLAGEN SCAFFOLD (CS)?

The FDA product code for REGEN COLLAGEN SCAFFOLD (CS) is OLC.

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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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