The following data is part of a premarket notification filed by Meril Life Sciences Private Limited with the FDA for Mozec - Rx Ptca Balloon Dilatation Catheter.
| Device ID | K131169 |
| 510k Number | K131169 |
| Device Name: | MOZEC - RX PTCA BALLOON DILATATION CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MERIL LIFE SCIENCES PRIVATE LIMITED 5523 RESEARCH PARK DR., SUITE 360 Baltimore, MD 21228 |
| Contact | H. Semih Oktay |
| Correspondent | H. Semih Oktay MERIL LIFE SCIENCES PRIVATE LIMITED 5523 RESEARCH PARK DR., SUITE 360 Baltimore, MD 21228 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-24 |
| Decision Date | 2013-12-24 |
| Summary: | summary |