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FDA 510(k)

SILIMED MALAR IMPLANT

K-Number: K981835 · 1998-07-09

ApplicantSilimed, LLC
Decision Date1998-07-09
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILIMED MALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Silimed, LLC. It received FDA 510(k) clearance on 1998-07-09 under 510(k) number K981835. 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 SILIMED MALAR IMPLANT?

SILIMED MALAR IMPLANT is a medical device that received FDA 510(k) clearance on 1998-07-09. The listed applicant is Silimed, LLC. The 510(k) number is K981835.

When did SILIMED MALAR IMPLANT receive FDA 510(k) clearance?

SILIMED MALAR IMPLANT received FDA 510(k) clearance on 1998-07-09, under 510(k) number K981835.

Who is the listed applicant for SILIMED MALAR IMPLANT?

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

What is the FDA product code for SILIMED MALAR IMPLANT?

The FDA product code for SILIMED MALAR IMPLANT is LZK.

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Other records listing Silimed, LLC 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.

K981852SILIMED TISSUE EXPANDERK974479SILIMED VAGINAL STENTK981850SILIMED CHIN IMPLANTSK981851SILIMED SILICONE CARVING BLOCKK981833SILIMED NASAL L SHAPED IMPLANTK980221SILIMED NASAL RETAINER

View all 9 devices →

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.K980141SPECTRUM DESIGNS PROJECTION MALAR IMPLANTSpectrum Designs, Inc.

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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