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FDA 510(k)

HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER

K-Number: K961511 · 1996-06-28

ApplicantLifecore Biomedical, Inc.
Decision Date1996-06-28
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER is the device name listed in this FDA 510(k) record. The listed applicant is Lifecore Biomedical, Inc.. It received FDA 510(k) clearance on 1996-06-28 under 510(k) number K961511. The device is classified under product code LZK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER?

HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Lifecore Biomedical, Inc.. The 510(k) number is K961511.

When did HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER receive FDA 510(k) clearance?

HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER received FDA 510(k) clearance on 1996-06-28, under 510(k) number K961511.

Who is the listed applicant for HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER?

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

What is the FDA product code for HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER?

The FDA product code for HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER is LZK.

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Other records listing Lifecore Biomedical, Inc. as applicant

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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Related Devices (Code: LZK)

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.

K021419AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.K002886IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)Implantech Associates, Inc.K992240PILLAR MALAR IMPLANTPillar Surgical, Inc.K983756SURGIFORM ANATOMICAL MALARSurgical Technology Laboratories, Inc.K982763SEARE BIOMEDICAL MALAR IMPLANTSSeare Biomedical Corp.K981835SILIMED MALAR IMPLANTSilimed, LLC

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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