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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BIOPAD 79022309 3253933 Live/Registered |
EURORESEARCH S.R.L. 2005-10-28 |