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510(k) Data Aggregation
K Number
K100847Device Name
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
Manufacturer
BIOCOMPATIBLES, INC.
Date Cleared
2010-05-21
(57 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WorldWide Medical Technologies Synthetic Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Rrachstherapy procedures.
Device Description
The devices are sterile, single patient use product.
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K Number
K083274Device Name
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
Manufacturer
BIOCOMPATIBLES, INC.
Date Cleared
2009-01-08
(63 days)
Product Code
KXK
Regulation Number
892.5730Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The World Wide Medical Technologies Anchor Marker and Marker Strand intended use is to, provide radiopaque markers for clearer identification of anatomic regions by providing reference positions around a proposed treatment site. They are indicated for use in brachytherapy, soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures
Device Description
Not Found
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