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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K871609
Device Name ULTRASOUND TRANSDUCER SHEATHS, STERILE
Applicant
Amedic USA
3702 E. Roeser Rd., Suite
27,P.O.B.62404
Phoenix,  AZ  85040
Applicant Contact JACK A MOORE
Correspondent
Amedic USA
3702 E. Roeser Rd., Suite
27,P.O.B.62404
Phoenix,  AZ  85040
Correspondent Contact JACK A MOORE
Regulation Number892.1570
Classification Product Code
ITX  
Date Received04/24/1987
Decision Date 07/15/1987
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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