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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K202517
Device Name Cytrellis Dermal Micro-Coring System
Applicant
Cytrellis Biosystems, Inc.
299c Washington St.
Woburn,  MA  01801
Applicant Contact Karen H. Cronholm
Correspondent
Cytrellis Biosystems, Inc.
299c Washington St.
Woburn,  MA  01801
Correspondent Contact Karen Cronholm
Regulation Number878.4430
Classification Product Code
QAI  
Date Received09/01/2020
Decision Date 07/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
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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