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Found 4 results
510(k) Data Aggregation
K Number
K003948Device Name
EPI-DERM SILICONE GEL SHEETING
Manufacturer
BIODERMIS CORP.
Date Cleared
2001-01-29
(39 days)
Product Code
MDA
Regulation Number
878.4025Why did this record match?
Applicant Name (Manufacturer) :
BIODERMIS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K992146Device Name
SCARAID SILICONE GEL SHEETING
Manufacturer
BIODERMIS CORP.
Date Cleared
1999-07-30
(36 days)
Product Code
MDA
Regulation Number
878.4025Why did this record match?
Applicant Name (Manufacturer) :
BIODERMIS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scaraid is intended for the management of hypertrophic and keloid scars and it is not intended to be used on open wounds.
Device Description
Not Found
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K Number
K991604Device Name
EPI-FOAM SILICONE SHEETING
Manufacturer
BIODERMIS CORP.
Date Cleared
1999-06-09
(30 days)
Product Code
MDA
Regulation Number
878.4025Why did this record match?
Applicant Name (Manufacturer) :
BIODERMIS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Epi-Foam Sheeting is intended for the management of hypertrophic and keloid scars. Epi-Foam is not intended for use on open wounds.
Device Description
Not Found
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K Number
K964047Device Name
CRYOSIL SILICONE GEL SHEETING
Manufacturer
BIODERMIS CORP.
Date Cleared
1997-03-19
(161 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
BIODERMIS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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