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Found 2 results

510(k) Data Aggregation

K Number

Device Name

SUILE OINTMENT WOUND DRESSING

Manufacturer

HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.

Date Cleared

2004-07-07

(78 days)

Product Code

FRO

Regulation Number

N/A

Why did this record match?

Applicant Name (Manufacturer) :

HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The SUILE Ointment Wound Dressing is indicated for the management of 1ª and 2ª4 degree burns, partial thickness wounds, donor sites and abrasions.

Device Description

SUILE Ointment Wound Dressing

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K Number

Device Name

SUILE WOUND DRESSING

Manufacturer

HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.

Date Cleared

2003-07-08

(305 days)

Product Code

FRO

Regulation Number

N/A

Why did this record match?

Applicant Name (Manufacturer) :

HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The SUILE Wound Dressing is indicated for the management of 1st and 2nd degree burns, partial thickness wounds, donor sites and abrasions.

Device Description

Not Found

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