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FDA 510(k)

PEC IMPLANT

K-Number: K913768 · 1992-02-03

ApplicantApplied Biomaterial Technologies
Decision Date1992-02-03
Product CodeMIC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PEC 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 1992-02-03 under 510(k) number K913768. 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 PEC IMPLANT?

PEC IMPLANT is a medical device that received FDA 510(k) clearance on 1992-02-03. The listed applicant is Applied Biomaterial Technologies. The 510(k) number is K913768.

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

PEC IMPLANT received FDA 510(k) clearance on 1992-02-03, under 510(k) number K913768.

Who is the listed applicant for PEC 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 PEC IMPLANT?

The FDA product code for PEC IMPLANT is MIC.

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 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 CHINK902284ZYMALAR IMPLANTK902285THE MAGNUM CHIN IMPLANTK902283THE NAUTILUS NASAL IMPLANT

View all 7 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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