Search Results
Found 2 results
510(k) Data Aggregation
K Number
K984374Device Name
SURGISORB
Manufacturer
SAMYANG CORP.
Date Cleared
1999-06-04
(179 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SAMYANG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.
Device Description
Survisorb brand absorbable suture is provided both dyed (D&C Viclet #2) and undyed (milk white), braided and monofiliment types and coated with polyceprolate and calcium sterate. Sizes offered are U.S.P. 8.0 through 2 (mstric equivalcht 0.4 through 5). Michaels. Polyglycolic acid. U.S.P. & polycaprolate and calcium sterate.
Ask a Question
K Number
K990363Device Name
BIOMESH BIODEGRADABLE GTR BARRIER
Manufacturer
SAMYANG CORP.
Date Cleared
1999-04-09
(63 days)
Product Code
NPK
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
SAMYANG CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BioMesh® Biodegradable GTR Barrier is intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures.
Indications for Use:
BioMesh® Biodegradable GTR Barrier is indicated for use in the treatment of the following specific conditions:
1. Two or three wall vertical defects.
2. Class II furcations.
3. Circumferrential defects.
4. Recession type defects.
5. Dehisence defects associated with dental implants
Device Description
BioMesh® Biodegradable GTR Barrier is provided as a single membrane type, but in a variety of precut shapes and sizes. Shapes and sizes. As noted on the graphic representation at the left, five different shapes are offered. The BioMesh® Biodegradable GTR Barrier is shape optimized to provide a ready made pattern well suited to the selected operative site needing a minimum of surgeon modification. If desired, the surgeon can trim any of the available shapes to fit unique or unusual circumstances. The BioMesh® Biodegradable GTR Barrier is made from polyglycolic acid with a coating of polylactic acid + polylactic glycolic acid copolymer. The membrane is constructed with interconnective pores with an embossed surface.
Ask a Question
Page 1 of 1