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FDA 510(k)

SILK*SKIN SCAR TREATMENT

K-Number: K941197 · 1994-08-11

ApplicantPuritas Health Care, Inc.
Decision Date1994-08-11
Product CodeMDA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILK*SKIN SCAR TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Puritas Health Care, Inc.. It received FDA 510(k) clearance on 1994-08-11 under 510(k) number K941197. 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 SILK*SKIN SCAR TREATMENT?

SILK*SKIN SCAR TREATMENT is a medical device that received FDA 510(k) clearance on 1994-08-11. The listed applicant is Puritas Health Care, Inc.. The 510(k) number is K941197.

When did SILK*SKIN SCAR TREATMENT receive FDA 510(k) clearance?

SILK*SKIN SCAR TREATMENT received FDA 510(k) clearance on 1994-08-11, under 510(k) number K941197.

Who is the listed applicant for SILK*SKIN SCAR TREATMENT?

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

What is the FDA product code for SILK*SKIN SCAR TREATMENT?

The FDA product code for SILK*SKIN SCAR TREATMENT is MDA.

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Other records listing Puritas Health Care, 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.

K942339SKIN NEUVEAU SCAR TREATMENTK935600TRACHEAL SUCTION CATHETERK935531OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIPK940074Y-TYPE BLOOD ADMINISTRATION SETK940055MULTISETK940054MEASURED VOLUME SOLUTION ADMINISTRATION SET

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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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