The following data is part of a premarket notification filed by Euroresearch S.r.l. with the FDA for Biopad.
| Device ID | K040283 |
| 510k Number | K040283 |
| Device Name: | BIOPAD |
| Classification | Dressing, Wound, Drug |
| Applicant | EURORESEARCH S.R.L. 1468 Harwell Avenue Crofton, MD 21114 |
| Contact | E. Smith |
| Correspondent | E. Smith EURORESEARCH S.R.L. 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-06 |
| Decision Date | 2005-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08054953400112 | K040283 | 000 |
| 08054953400105 | K040283 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOPAD 79022309 3253933 Live/Registered |
EURORESEARCH S.R.L. 2005-10-28 |