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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
510(k) Number K170655
Device Name Zepto
Applicant
Mynosys Cellular Devices, Inc.
46710 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact Dan Marinsik
Correspondent
Mynosys Cellular Devices, Inc.
46710 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact Dan Marinsik
Regulation Number886.4100
Classification Product Code
PUL  
Date Received03/03/2017
Decision Date 06/02/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT02890303
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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