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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 K843634
Device Name ASC 4080 SYSTEM
Applicant
Atlantis Scientific Corp.
4377 W 96th St.
Indianapolis,  IN  46268
Applicant Contact LARRY W DENNEY
Correspondent
Atlantis Scientific Corp.
4377 W 96th St.
Indianapolis,  IN  46268
Correspondent Contact LARRY W DENNEY
Regulation Number890.1615
Classification Product Code
IKE  
Date Received09/17/1984
Decision Date 11/08/1984
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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