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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical
510(k) Number K200238
Device Name ControlRad Sterile Cover
Applicant
Controlrad, Inc.
275 Scientific Dr. NW #1100
Norcross,  GA  30092
Applicant Contact Chris Fair
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number878.4370
Classification Product Code
KKX  
Date Received01/31/2020
Decision Date 04/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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