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Found 4 results
510(k) Data Aggregation
K Number
DEN090005Device Name
PRINEO SKIN CLOSURE SYSTEM
Manufacturer
CLOSURE MEDICAL CORP.
Date Cleared
2010-04-30
(402 days)
Product Code
OMD
Regulation Number
878.4011Why did this record match?
Applicant Name (Manufacturer) :
CLOSURE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002338Device Name
LIQUIDERM LIQUID ADHESIVE BANDAGE
Manufacturer
CLOSURE MEDICAL CORP.
Date Cleared
2001-01-29
(181 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
CLOSURE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991923Device Name
SOOTHE-N-SEAL CANKER SORE RELIEF
Manufacturer
CLOSURE MEDICAL CORP.
Date Cleared
1999-09-02
(87 days)
Product Code
MZW
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
CLOSURE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides immediate and long lasting relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.
Device Description
SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a non-sterile, clear, colorless, free-flowing liquid protectant packaged in high-density polyethylene multipleuse, controlled dropper bottles. The device package contains one gram of liquid protectant and 10 double-ended applicator swabs in a transparent polyethylene terephthalate tray with cardboard display label. Each end of the swab handle consists of a polyurethane foam sponge tip, one end rounded for drying the ulcer area and one end pointed for device application.
SOOTHE-N-SEAL™ Canker Sore Relief is composed of 2-octyl cyanoacrylate (>99%) with small amounts of polymerization inhibitors added to enhance shelf life.
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K Number
K980159Device Name
OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
Manufacturer
CLOSURE MEDICAL CORP.
Date Cleared
1998-04-09
(83 days)
Product Code
EMA
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
CLOSURE MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Octyldent® is intended for use as an adhesive for the temporary fixing of periodontal polymer or fibers in periodontal pockets.
Device Description
Not Found
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