Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix

Sizer, Mammary, Breast Implant Volume

Motiva USA, LLC

The following data is part of a premarket notification filed by Motiva Usa, Llc with the FDA for Intraoperative, Single-use, Sterile, Silicone Breast Sizer Motiva Implant Matrix.

Pre-market Notification Details

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• Device ID: K183163
• 510k Number: K183163
• Device Name: Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
• Classification: Sizer, Mammary, Breast Implant Volume
• Applicant: Motiva USA, LLC 712 Fifth Avenue 14th Floor New York, NY 10019 -4108
• Contact: Alberto Quesada Rivera
• Correspondent: Michael J. Billig; Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110
• Product Code: MRD
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-15
• Decision Date: 2019-02-05
• Summary: summary