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FDA 510(k)

EXTENDED MALAR IMPLANT

K-Number: K911515 · 1991-07-01

ApplicantImplantech Associates, Inc.
Decision Date1991-07-01
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EXTENDED MALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 1991-07-01 under 510(k) number K911515. 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 EXTENDED MALAR IMPLANT?

EXTENDED MALAR IMPLANT is a medical device that received FDA 510(k) clearance on 1991-07-01. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K911515.

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

EXTENDED MALAR IMPLANT received FDA 510(k) clearance on 1991-07-01, under 510(k) number K911515.

Who is the listed applicant for EXTENDED MALAR IMPLANT?

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

What is the FDA product code for EXTENDED MALAR IMPLANT?

The FDA product code for EXTENDED MALAR IMPLANT is LZK.

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Other records listing Implantech Associates, 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.

K200610Customized Contour ImplantK191130Customized Contour ImplantK172389ePTFE-Coated Auricular ImplantK071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXK052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XK052505CALF IMPLANT, MODEL EC17-X

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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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