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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Imager, Ultrasonic Obstetric-Gynecologic
510(k) Number K862627
Device Name SONORANGER TRANSVAGINAL PROBE
Applicant
Ausonics Pty , Ltd.
40 Crane Hill Rd.
Suffield,  CT  06078
Applicant Contact WILLIAM C NEALON
Correspondent
Ausonics Pty , Ltd.
40 Crane Hill Rd.
Suffield,  CT  06078
Correspondent Contact WILLIAM C NEALON
Regulation Number884.2225
Classification Product Code
HEM  
Date Received07/10/1986
Decision Date 08/01/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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