ASSUFIL
Suture, Absorbable, Synthetic, Polyglycolic Acid
ASSUT EUROPE S.P.A.
The following data is part of a premarket notification filed by Assut Europe S.p.a. with the FDA for Assufil.
Pre-market Notification Details
| Device ID | K021767 |
| 510k Number | K021767 |
| Device Name: | ASSUFIL |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ASSUT EUROPE S.P.A. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Contact | Lucio Improta |
| Correspondent | Lucio Improta ASSUT EUROPE S.P.A. 10147 UMBERLAND PLACE Boca Raton, FL 33428 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-29 |
| Decision Date | 2002-11-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38033439372847 | K021767 | 000 |
| 18033439372812 | K021767 | 000 |
| 38033439003154 | K021767 | 000 |
| 38033439003277 | K021767 | 000 |
| 38033439003352 | K021767 | 000 |
| 38033439003833 | K021767 | 000 |
| 38033439003895 | K021767 | 000 |
| 38033439043051 | K021767 | 000 |
| 38033439094459 | K021767 | 000 |
| 38033439372830 | K021767 | 000 |
| 18033439002382 | K021767 | 000 |
Trademark Results [ASSUFIL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ASSUFIL 88703947 not registered Live/Pending |
KALANTARI, ARASH R 2019-11-22 |
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