The following data is part of a premarket notification filed by Assut Europe S.p.a. with the FDA for Assut Filbloc Permanent Sutures.
| Device ID | K171039 |
| 510k Number | K171039 |
| Device Name: | Assut Filbloc Permanent Sutures |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | Assut Europe S.p.A. Zona Industriale Magliano Dei Marsi, IT 67062 |
| Contact | Gloria Aggio |
| Correspondent | Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, IT 00153 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-06 |
| Decision Date | 2017-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18033439180042 | K171039 | 000 |
| 18033439178889 | K171039 | 000 |
| 18033439169238 | K171039 | 000 |
| 18033439164295 | K171039 | 000 |
| 38033439008968 | K171039 | 000 |
| 38033439007770 | K171039 | 000 |
| 38033439007435 | K171039 | 000 |
| 38033439007190 | K171039 | 000 |
| 38033439007138 | K171039 | 000 |