The following data is part of a premarket notification filed by Fidia Advanced Biopolymers Srl with the FDA for Laserskin Dressing.
| Device ID | K001508 |
| 510k Number | K001508 |
| Device Name: | LASERSKIN DRESSING |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | FIDIA ADVANCED BIOPOLYMERS SRL VIA PONTE DELLA FABBRICA,3/A 35031 Abano Terme (pd), IT 35031 |
| Contact | Paolo Rampazzo |
| Correspondent | Paolo Rampazzo FIDIA ADVANCED BIOPOLYMERS SRL VIA PONTE DELLA FABBRICA,3/A 35031 Abano Terme (pd), IT 35031 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-15 |
| Decision Date | 2001-07-25 |