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, Mozec Nc – Rx Ptca Balloon Dilatation Catheter.
| Device ID | K181023 |
| 510k Number | K181023 |
| Device Name: | Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Meril Life Sciences Private Limited Bilakhia House, Survey No. 135/139, Muktanand Marg, Chala Vapi, IN 396191 |
| Contact | Utpal Thakor |
| Correspondent | H. Semith Oktay CardioMed Device Consultants, LLC 1783 Forest Drive, # 254 Annapolis, MD 21401 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-17 |
| Decision Date | 2018-05-17 |
| Summary: | summary |