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510(k) Data Aggregation
K Number
K965256Device Name
DMS-1000C DERMOABRADER
Manufacturer
Date Cleared
1996-12-09
(115 days)
Product Code
Regulation Number
878.4820Why did this record match?
Product Code :
GFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K962371Device Name
DERMTOME BLADE
Manufacturer
Date Cleared
1996-08-29
(71 days)
Product Code
Regulation Number
878.4820Why did this record match?
Product Code :
GFD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DSP Worldwide Snowden-Pencer Dermatome Blade is intended for use as an accessory to Padgett type dermatomes.
Device Description
The DSP Worldwide Snowden-Pencer Dermatome Blade is secured to the Padgett Dermatome head using the securing nut. The blade oscillates on the horizontal plane to harvest a split thickness of skin from a donor site for grafting. It is provided in one size only and consists of the stainless steel used for many surgical applications. Blades are provided sterile, single use, and disposable in individual Tyvek and polypropylene pouches. Devices are sterilized using gamma sterilization.
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