Filbloc

Suture, Surgical, Absorbable, Polydioxanone

ASSUT EUROPE

The following data is part of a premarket notification filed by Assut Europe with the FDA for Filbloc.

Pre-market Notification Details

• Device ID: K150553
• 510k Number: K150553
• Device Name: Filbloc
• Classification: Suture, Surgical, Absorbable, Polydioxanone
• Applicant: ASSUT EUROPE ZONA INDUSTRIALE Magliano Dei Marsi, IT 1-67062
• Contact: Gloria Aggio
• Correspondent: Rhonda Alexander; REGISTRAR CORP 144 RESEARCH DRIVE Hampton, VA 23666
• Product Code: NEW
• CFR Regulation Number: 878.4840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-04
• Decision Date: 2016-05-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
18033439114085	K150553	000
78033439360880	K150553	000
18033439133284	K150553	000
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08033439195834	K150553	000
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18033439183715	K150553	000
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38033439004625	K150553	000
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18033439133628	K150553	000
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18033439150007	K150553	000
78033439360835	K150553	000
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18033439195886	K150553	000
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78033439171387	K150553	000
78033439171394	K150553	000
78033439171400	K150553	000
78033439173558	K150553	000
78033439173565	K150553	000
78033439180501	K150553	000
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18033439173587	K150553	000
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08033439168449	K150553	000
08033439168456	K150553	000
78033439181331	K150553	000
18033439160884	K150553	000
78033439180655	K150553	000