Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE

Sizer, Mammary, Breast Implant Volume

MENTOR WORLDWIDE LLC

The following data is part of a premarket notification filed by Mentor Worldwide Llc with the FDA for Mentor Memoryshape Resterilizable Gel Breast Implant Sizer Sterile.

Pre-market Notification Details

• Device ID: K151055
• 510k Number: K151055
• Device Name: Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
• Classification: Sizer, Mammary, Breast Implant Volume
• Applicant: MENTOR WORLDWIDE LLC 201 MENTOR DRIVE Santa Barbara, CA 93111
• Contact: Sarah Mcmanus
• Correspondent: Sarah Mcmanus; MENTOR WORLDWIDE LLC 201 MENTOR DRIVE Santa Barbara, CA 93111
• Product Code: MRD
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-04-20
• Decision Date: 2015-05-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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