MOLLI

Marker, Radiographic, Implantable

MOLLI Surgical, Inc.

The following data is part of a premarket notification filed by Molli Surgical, Inc. with the FDA for Molli.

Pre-market Notification Details

• Device ID: K210600
• 510k Number: K210600
• Device Name: MOLLI
• Classification: Marker, Radiographic, Implantable
• Applicant: MOLLI Surgical, Inc. 22 St. Clair Ave. East, Suite #1500 Toronto, CA M4t 2s3
• Contact: Frazila Seker
• Correspondent: Pierre Bounaud; AcKnowlegde Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110
• Product Code: NEU
• CFR Regulation Number: 878.4300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-01
• Decision Date: 2021-04-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850024195035	K210600	000
00850024195011	K210600	000
00850024195004	K210600	000
00850024195080	K210600	000