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FDA 510(k)

MEDIAL MALAR IMPLANT

K-Number: K961080 · 1996-04-19

ApplicantRand Scientific Corp.
Decision Date1996-04-19
Product CodeLZK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDIAL MALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Rand Scientific Corp.. It received FDA 510(k) clearance on 1996-04-19 under 510(k) number K961080. 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 MEDIAL MALAR IMPLANT?

MEDIAL MALAR IMPLANT is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is Rand Scientific Corp.. The 510(k) number is K961080.

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

MEDIAL MALAR IMPLANT received FDA 510(k) clearance on 1996-04-19, under 510(k) number K961080.

Who is the listed applicant for MEDIAL MALAR IMPLANT?

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

What is the FDA product code for MEDIAL MALAR IMPLANT?

The FDA product code for MEDIAL MALAR IMPLANT is LZK.

Related Clinical Trials

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.

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Other records listing Rand Scientific 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.

K963856RAND NASAL PACKINGK961081SPIRIT RIDGE SILICONE CARVING BLOCKK961057DURALASTIC SHEETING IIK955777PMMA CLASICK961071THE MAGNUM CHIN IMPLANTK961072PEC 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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