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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K202284
Device Name Oncospace
Applicant
Oncospace, Inc.
1812 Ashland Ave., Suite 100k
Baltimore,  MD  21205
Applicant Contact Praveen Sinha
Correspondent
Oncospace, Inc.
1812 Ashland Ave., Suite 100k
Baltimore,  MD  21205
Correspondent Contact Praveen Sinha
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/12/2020
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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