Mozec NC-Rx PTCA Baloon Dilatation Catheter

Catheters, Transluminal Coronary Angioplasty, Percutaneous

MERIL LIFE SCIENCES PRIVATE LIMITED

The following data is part of a premarket notification filed by Meril Life Sciences Private Limited with the FDA for Mozec Nc-rx Ptca Baloon Dilatation Catheter.

Pre-market Notification Details

• Device ID: K160961
• 510k Number: K160961
• Device Name: Mozec NC-Rx PTCA Baloon 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. Semih Oktay; CardioMed Device Consultants, LLC 5523 Research Park Drive, Suite 205 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: 2016-04-05
• Decision Date: 2016-07-30
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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