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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Vessel Occlusion
510(k) Number K891180
Device Name TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT
Applicant
Ingress Technologies, Inc.
3702 E. Roeser Rd., Suite 27
P.O. Box 62404
Phoenix,  AZ  85082
Applicant Contact SHANE H ABOWITT
Correspondent
Ingress Technologies, Inc.
3702 E. Roeser Rd., Suite 27
P.O. Box 62404
Phoenix,  AZ  85082
Correspondent Contact SHANE H ABOWITT
Regulation Number870.2890
Classification Product Code
DXP  
Date Received03/06/1989
Decision Date 06/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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