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FDA 510(k)

PERMAMESH-D HYDROXYLAPATITE MATRIX

K-Number: K960354 · 1996-03-20

ApplicantCeramed Corp.
Decision Date1996-03-20
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PERMAMESH-D HYDROXYLAPATITE MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Ceramed Corp.. It received FDA 510(k) clearance on 1996-03-20 under 510(k) number K960354. 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 PERMAMESH-D HYDROXYLAPATITE MATRIX?

PERMAMESH-D HYDROXYLAPATITE MATRIX is a medical device that received FDA 510(k) clearance on 1996-03-20. The listed applicant is Ceramed Corp.. The 510(k) number is K960354.

When did PERMAMESH-D HYDROXYLAPATITE MATRIX receive FDA 510(k) clearance?

PERMAMESH-D HYDROXYLAPATITE MATRIX received FDA 510(k) clearance on 1996-03-20, under 510(k) number K960354.

Who is the listed applicant for PERMAMESH-D HYDROXYLAPATITE MATRIX?

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

What is the FDA product code for PERMAMESH-D HYDROXYLAPATITE MATRIX?

The FDA product code for PERMAMESH-D HYDROXYLAPATITE MATRIX is LZK.

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Other records listing Ceramed Corp. 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.

K962838PERMARIDGE SYRINGEK962786OSTEOGRAF STAINLESS STEEL SYRINGK960348OSTEOGRAF/N-300 HYDROXYLAPATITEK960368OSTEOGRAFT/N-700 HYDROXYLAPTITEK960353OSTEOGRAF/LD-300 HYDROXYLAPATITEK960361PERMAMESH-D HYDROXYLAPATITE MATRIX

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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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