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FDA 510(k), K153611, Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
FDA 510(k), K153611, Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
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510(K) Number: K153611
Device Name: Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
Manufacturer: Ethicon, LLC
Device Classification Name: suture, absorbable, synthetic, polyglycolic acid
Regulation Number: 878.4493
Classification Product Code: GAM
Date Received: 12/17/2015
Decision Date: 06/03/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND Polybutilate Coated Polyester Sterile Synthetic Non-Absorbable Suture Cartridges, PROXISURE Suturing Device
Manufacturer: Ethicon, LLC
Device Classification Name: suture, absorbable, synthetic, polyglycolic acid
Regulation Number: 878.4493
Classification Product Code: GAM
Date Received: 12/17/2015
Decision Date: 06/03/2016
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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