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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryophthalmic
510(k) Number K202038
Device Name CryoTreQ
Applicant
VitreQ BV
Segglant-Noord 2
Vierpolders,  NL 3237MG
Applicant Contact Christian Neele
Correspondent
Dynamic Strategies, Inc.
25 Granite St.
Medway,  MA  02053
Correspondent Contact Debora Stapleton
Regulation Number886.4170
Classification Product Code
HPS  
Date Received07/23/2020
Decision Date 12/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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