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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K883372
Device Name ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
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 Number892.1650
Classification Product Code
JAA  
Date Received08/10/1988
Decision Date 11/25/1988
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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