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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 K981678
Device Name STRATA, MODEL V.O.95
Applicant
Rosses Medical Systems
10620 Guilford Rd., Suite 201
Jessup,  MD  20794
Applicant Contact RENE SPECTOR
Correspondent
Rosses Medical Systems
10620 Guilford Rd., Suite 201
Jessup,  MD  20794
Correspondent Contact RENE SPECTOR
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received05/12/1998
Decision Date 12/11/1998
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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