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FDA 510(k)

ZYMALAR IMPLANT

K-Number: K902284 · 1990-09-12

ApplicantApplied Biomaterial Technologies
Decision Date1990-09-12
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZYMALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Applied Biomaterial Technologies. It received FDA 510(k) clearance on 1990-09-12 under 510(k) number K902284. 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 ZYMALAR IMPLANT?

ZYMALAR IMPLANT is a medical device that received FDA 510(k) clearance on 1990-09-12. The listed applicant is Applied Biomaterial Technologies. The 510(k) number is K902284.

When did ZYMALAR IMPLANT receive FDA 510(k) clearance?

ZYMALAR IMPLANT received FDA 510(k) clearance on 1990-09-12, under 510(k) number K902284.

Who is the listed applicant for ZYMALAR IMPLANT?

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

What is the FDA product code for ZYMALAR IMPLANT?

The FDA product code for ZYMALAR IMPLANT is LZK.

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Other records listing Applied Biomaterial Technologies 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.

K935571DURALASTIC SHEETINGK945552DURALASTIC SHEETINGK931500THE PERMARIDGE MATRIX CHINK913768PEC IMPLANTK902285THE MAGNUM CHIN IMPLANTK902283THE NAUTILUS NASAL IMPLANT

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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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