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Found 3 results
510(k) Data Aggregation
K Number
K971252Device Name
SEVRAIN CRANIAL CLAMP
Manufacturer
IKONOS CORP.
Date Cleared
1998-07-06
(459 days)
Product Code
GXN
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
IKONOS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SCC-100 is indicated for the re-attachment of the bone flap after a craniotomy.
Device Description
Not Found
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K Number
K971408Device Name
SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)
Manufacturer
IKONOS CORP.
Date Cleared
1998-05-12
(391 days)
Product Code
GXN
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
IKONOS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SCC 200 is indicated for use as a means to cover the burr hole and reattach the bone flap after a craniotomy procedure. The SCC 200 is not intended for use where only a single burr hole is made.
Device Description
Sevrain Cranial Clamp 200 Series (Polyethylene)
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K Number
K971454Device Name
TYMPANOSTOMY VENTILATION TUBE
Manufacturer
IKONOS CORP.
Date Cleared
1997-05-29
(38 days)
Product Code
ETD
Regulation Number
874.3880Why did this record match?
Applicant Name (Manufacturer) :
IKONOS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ventilation tubes are indicated where cases of enstachian tube dysfunction fails to respond conventional therapy. This includes : Chronic otitis Media with effusion (serous , mucoid, or pur ulent). Recurrent acute ofitis Media . persistent high negative A record of with associated middle ear pressure, hearing conductive Symptomatic otalgia, vertige and for timmitas brangia, version of the tympanic membraine.
Device Description
Tympanostomy Ventilation Tube-TVT 800
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