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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K853147
Device Name SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY
Applicant
Scano, Inc.
2776 N. Triphammer Rd., Rd. 1
Ithaca,  NY  14850
Applicant Contact WENDELL HAUTANIEM
Correspondent
Scano, Inc.
2776 N. Triphammer Rd., Rd. 1
Ithaca,  NY  14850
Correspondent Contact WENDELL HAUTANIEM
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/29/1985
Decision Date 03/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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