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FDA 510(k)

SKAR-KARE SHEET

K-Number: K980563 · 1998-05-20

ApplicantLife Medical Sciences, Inc.
Decision Date1998-05-20
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SKAR-KARE SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Life Medical Sciences, Inc.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K980563. 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 SKAR-KARE SHEET?

SKAR-KARE SHEET is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Life Medical Sciences, Inc.. The 510(k) number is K980563.

When did SKAR-KARE SHEET receive FDA 510(k) clearance?

SKAR-KARE SHEET received FDA 510(k) clearance on 1998-05-20, under 510(k) number K980563.

Who is the listed applicant for SKAR-KARE SHEET?

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

What is the FDA product code for SKAR-KARE SHEET?

The FDA product code for SKAR-KARE SHEET is MDA.

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Other records listing Life Medical Sciences, Inc. as applicant

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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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