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510(k) Data Aggregation
K Number
K040042Device Name
MEDISIL SILICONE SHEETING
Manufacturer
MEDISIL CORPORATION
Date Cleared
2004-04-01
(80 days)
Product Code
MIB
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
MEDISIL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sheeting is indicated for short term use for nasal splinting, wound dressings, scar coverings and temporary joint spacers.
For long term use, this device is indicated for tympanic membrane repair, dural covering, nasal septal repair, tendon anastamosis and neural repair, correction of strabismus, galea repair, orbital floor repair, hemodialysis shunt anchors, facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel and repair of orbital floor fractures.
Device Description
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