Zepto

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered

Mynosys Cellular Devices, Inc.

The following data is part of a premarket notification filed by Mynosys Cellular Devices, Inc. with the FDA for Zepto.

Pre-market Notification Details

• Device ID: K170655
• 510k Number: K170655
• Device Name: Zepto
• Classification: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
• Applicant: Mynosys Cellular Devices, Inc. 46710 Fremont Blvd. Fremont, CA 94538 -6538
• Contact: Dan Marinsik
• Correspondent: Dan Marinsik; Mynosys Cellular Devices, Inc. 46710 Fremont Blvd. Fremont, CA 94538 -6538
• Product Code: PUL
• CFR Regulation Number: 886.4100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-03
• Decision Date: 2017-06-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B560Z20200	K170655	000
B560C20200	K170655	000