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FDA 510(k)

EVANESCE SCAR MANAGEMENT SYSTEM

K-Number: K981387 · 1998-06-10

ApplicantMedical Scientific, Inc.
Decision Date1998-06-10
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EVANESCE SCAR MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Scientific, Inc.. It received FDA 510(k) clearance on 1998-06-10 under 510(k) number K981387. 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 EVANESCE SCAR MANAGEMENT SYSTEM?

EVANESCE SCAR MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-10. The listed applicant is Medical Scientific, Inc.. The 510(k) number is K981387.

When did EVANESCE SCAR MANAGEMENT SYSTEM receive FDA 510(k) clearance?

EVANESCE SCAR MANAGEMENT SYSTEM received FDA 510(k) clearance on 1998-06-10, under 510(k) number K981387.

Who is the listed applicant for EVANESCE SCAR MANAGEMENT SYSTEM?

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

What is the FDA product code for EVANESCE SCAR MANAGEMENT SYSTEM?

The FDA product code for EVANESCE SCAR MANAGEMENT SYSTEM is MDA.

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 Medical Scientific, 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.

K071832MODIFCATION TO: SPYGLASS IRRIGATION SYSTEMK063700SPYGLASS IRRIGATION SYSTEMK031564CSSK011202MSI BIPOLAR SHEATH

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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