FDA 510(k)

PERMAMESH HYDROXYLAPATITE MATRIX

K-Number: K921468 · 1992-08-21

Decision Date1992-08-21

Product CodeLYC

Advisory CommitteeDE

DecisionSubstantially Equivalent for Some Indications

Device Summary

PERMAMESH 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 1992-08-21 under 510(k) number K921468. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PERMAMESH HYDROXYLAPATITE MATRIX?

PERMAMESH HYDROXYLAPATITE MATRIX is a medical device that received FDA 510(k) clearance on 1992-08-21. The listed applicant is Ceramed Corp.. The 510(k) number is K921468.

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

PERMAMESH HYDROXYLAPATITE MATRIX received FDA 510(k) clearance on 1992-08-21, under 510(k) number K921468.

Who is the listed applicant for PERMAMESH 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 HYDROXYLAPATITE MATRIX?

The FDA product code for PERMAMESH HYDROXYLAPATITE MATRIX is LYC.

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Other records listing Ceramed Corp. as applicant

K962838PERMARIDGE SYRINGE K962786OSTEOGRAF STAINLESS STEEL SYRING K960348OSTEOGRAF/N-300 HYDROXYLAPATITE K960368OSTEOGRAFT/N-700 HYDROXYLAPTITE K960353OSTEOGRAF/LD-300 HYDROXYLAPATITE K960361PERMAMESH-D HYDROXYLAPATITE MATRIX

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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.