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 |