The following data is part of a premarket notification filed by Elcam Medical A.c.a.l. with the FDA for Bacstop.
Device ID | K053405 |
510k Number | K053405 |
Device Name: | BACSTOP |
Classification | Stopcock, I.v. Set |
Applicant | ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
Contact | Tali Hazan |
Correspondent | Tali Hazan ELCAM MEDICAL A.C.A.L. KIBBUTZ BAR-AM D.n. Merom Hagalil, IL 13860 |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-07 |
Decision Date | 2006-05-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BACSTOP 77440457 3618420 Live/Registered |
Core Resources, Inc. 2008-04-04 |
BACSTOP 77223911 3494780 Dead/Cancelled |
Neutraspore, Inc. 2007-07-06 |
BACSTOP 75772471 2351997 Dead/Cancelled |
Future Products Corporation 1999-08-10 |
BACSTOP 75162839 2085971 Dead/Cancelled |
SciTech Dental, Inc. 1996-09-09 |
BACSTOP 73671049 1475821 Dead/Cancelled |
STAAR SURGICAL CO., INC. 1987-07-10 |