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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K073681
Device Name NANOBEAM 940, MODEL 940-900-02
Applicant
Davaray, Inc.
2232 S. Main St.
Suite 422
Ann Arbor,  MI  48103
Applicant Contact DAVID J ARNDT
Correspondent
Davaray, Inc.
2232 S. Main St.
Suite 422
Ann Arbor,  MI  48103
Correspondent Contact DAVID J ARNDT
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/28/2007
Decision Date 12/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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