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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K902967
Device Name MICRO-EMED-SYSTEM
Applicant
Novel Electronics, Inc.
511 Eleventh Ave. S.
Suite 266, Box 82
Minneapolis,  MN  55415
Applicant Contact SUSAN DIEKRAGER
Correspondent
Novel Electronics, Inc.
511 Eleventh Ave. S.
Suite 266, Box 82
Minneapolis,  MN  55415
Correspondent Contact SUSAN DIEKRAGER
Regulation Number890.1615
Classification Product Code
IKE  
Date Received07/06/1990
Decision Date 09/17/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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