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FDA 510(k)

PMT NEW BEGINNINGS GELSHAPES & AMEND

K-Number: K972597 · 1997-10-01

ApplicantPmt Corp.
Decision Date1997-10-01
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PMT NEW BEGINNINGS GELSHAPES & AMEND is the device name listed in this FDA 510(k) record. The listed applicant is Pmt Corp.. It received FDA 510(k) clearance on 1997-10-01 under 510(k) number K972597. The device is classified under product code MDA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMT NEW BEGINNINGS GELSHAPES & AMEND?

PMT NEW BEGINNINGS GELSHAPES & AMEND is a medical device that received FDA 510(k) clearance on 1997-10-01. The listed applicant is Pmt Corp.. The 510(k) number is K972597.

When did PMT NEW BEGINNINGS GELSHAPES & AMEND receive FDA 510(k) clearance?

PMT NEW BEGINNINGS GELSHAPES & AMEND received FDA 510(k) clearance on 1997-10-01, under 510(k) number K972597.

Who is the listed applicant for PMT NEW BEGINNINGS GELSHAPES & AMEND?

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

What is the FDA product code for PMT NEW BEGINNINGS GELSHAPES & AMEND?

The FDA product code for PMT NEW BEGINNINGS GELSHAPES & AMEND is MDA.

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Other records listing Pmt 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.

K122376PMT TRUSCAN SURFACE ELECTRODEK090733PMT HALO SYSTEMK082474PMT SUBDURAL CORTICAL ELECTRODESK042901ENDOMARK STERILE INDIA INKK033730PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIESK970418PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)

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Related Devices (Code: MDA)

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.

K112131NEODYNE DRESSINGNeodyne Biosciences, Inc.K111733CORELEADER SCAR-DIMMERCoreleader Biotech Co., Ltd.K083718BEAU RX SCAR CARE GELBeau RX Solutions, LLCK053481KELO-COTE SPRAYAdvanced Bio-Technologies, Inc.K041704NEWGEL AND NEWGEL PLUS ENewmedical Technology, Inc.K040307HANSON SCAR ADEHanson Medical, 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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