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FDA 510(k)

CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G

K-Number: K042730 · 2005-02-14

ApplicantLifecorebiomedical
Decision Date2005-02-14
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G is the device name listed in this FDA 510(k) record. The listed applicant is Lifecorebiomedical. It received FDA 510(k) clearance on 2005-02-14 under 510(k) number K042730. 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 CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G?

CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G is a medical device that received FDA 510(k) clearance on 2005-02-14. The listed applicant is Lifecorebiomedical. The 510(k) number is K042730.

When did CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G receive FDA 510(k) clearance?

CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G received FDA 510(k) clearance on 2005-02-14, under 510(k) number K042730.

Who is the listed applicant for CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G?

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

What is the FDA product code for CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G?

The FDA product code for CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G 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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