The following data is part of a premarket notification filed by Merck Millipore Ltd. with the FDA for Vented Millex -gv, Cathivex -gv.
Device ID | K133004 |
510k Number | K133004 |
Device Name: | VENTED MILLEX -GV, CATHIVEX -GV |
Classification | Filter, Conduction, Anesthetic |
Applicant | MERCK MILLIPORE LTD. 28820 SINGLE OAK DRIVE Temecula, CA 92590 |
Contact | Cindy Penny |
Correspondent | Cindy Penny MERCK MILLIPORE LTD. 28820 SINGLE OAK DRIVE Temecula, CA 92590 |
Product Code | BSN |
CFR Regulation Number | 868.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-09-25 |
Decision Date | 2014-03-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04054839076619 | K133004 | 000 |