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FDA 510(k)

SPECTRUM DISIGNS PECTORAL IMPLANT

K-Number: K944163 · 1994-11-07

ApplicantSpectrum Designs, Inc.
Decision Date1994-11-07
Product CodeMIC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SPECTRUM DISIGNS PECTORAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Designs, Inc.. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K944163. The device is classified under product code MIC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRUM DISIGNS PECTORAL IMPLANT?

SPECTRUM DISIGNS PECTORAL IMPLANT is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Spectrum Designs, Inc.. The 510(k) number is K944163.

When did SPECTRUM DISIGNS PECTORAL IMPLANT receive FDA 510(k) clearance?

SPECTRUM DISIGNS PECTORAL IMPLANT received FDA 510(k) clearance on 1994-11-07, under 510(k) number K944163.

Who is the listed applicant for SPECTRUM DISIGNS PECTORAL IMPLANT?

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

What is the FDA product code for SPECTRUM DISIGNS PECTORAL IMPLANT?

The FDA product code for SPECTRUM DISIGNS PECTORAL IMPLANT is MIC.

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Other records listing Spectrum Designs, 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.

K992522SPECTRUM DESIGNS SPECTRAGELK982688SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCKK980445SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANTK980463SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANTK980444SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANTK980446SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT

View all 18 devices →

Related Devices (Code: MIC)

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.

K021337AART PECTORALIS IMPLANTAesthetic and Reconstructive Technologies, Inc.K002633SILMAX PECTORAL IMPLANTPillar Surgical, Inc.K983043SEARE BIOMEDICAL SILICONE BLOCKSeare Biomedical Corp.K982762SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.K973729POWERFLEX PEC IMPLANTHanson Medical, Inc.K961072PEC IMPLANTRand Scientific Corp.

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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