The following data is part of a premarket notification filed by Fidia Advanced Biopolymers Srl with the FDA for Jaloskin.
Device ID | K092257 |
510k Number | K092257 |
Device Name: | JALOSKIN |
Classification | Dressing, Wound, Drug |
Applicant | FIDIA ADVANCED BIOPOLYMERS SRL 1111 PENNSYLVANIA AVE NW Washington, DC 20004 |
Contact | Sharon A Segal |
Correspondent | Sharon A Segal FIDIA ADVANCED BIOPOLYMERS SRL 1111 PENNSYLVANIA AVE NW Washington, DC 20004 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2009-07-28 |
Decision Date | 2010-01-26 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
JALOSKIN 75400839 not registered Dead/Abandoned |
E. R. SQUIBB & SONS, INC. 1997-12-05 |