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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K173046
Device Name Cocoon Portable Handheld X-Ray System
Applicant
Dexcowin Co., Ltd.
#905, 2, Gasan Digital 1-Ro, Geumcheon-Gu
Seoul,  KR 08591
Applicant Contact Ryu Seung-Bum
Correspondent
Denterprise International, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact Joyce St. Germain
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/28/2017
Decision Date 10/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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