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FDA 510(k)

PMT(R) SILICONE GEL SHEETING MODEL 3505-1

K-Number: K930409 · 1993-09-01

ApplicantPmt Corp.
Decision Date1993-09-01
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PMT(R) SILICONE GEL SHEETING MODEL 3505-1 is the device name listed in this FDA 510(k) record. The listed applicant is Pmt Corp.. It received FDA 510(k) clearance on 1993-09-01 under 510(k) number K930409. 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(R) SILICONE GEL SHEETING MODEL 3505-1?

PMT(R) SILICONE GEL SHEETING MODEL 3505-1 is a medical device that received FDA 510(k) clearance on 1993-09-01. The listed applicant is Pmt Corp.. The 510(k) number is K930409.

When did PMT(R) SILICONE GEL SHEETING MODEL 3505-1 receive FDA 510(k) clearance?

PMT(R) SILICONE GEL SHEETING MODEL 3505-1 received FDA 510(k) clearance on 1993-09-01, under 510(k) number K930409.

Who is the listed applicant for PMT(R) SILICONE GEL SHEETING MODEL 3505-1?

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(R) SILICONE GEL SHEETING MODEL 3505-1?

The FDA product code for PMT(R) SILICONE GEL SHEETING MODEL 3505-1 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 SERIESK972597PMT NEW BEGINNINGS GELSHAPES & AMEND

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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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