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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 K853116
Device Name PAXIAL
Applicant
Biophysic Medical, Inc.
40 Crane Hill Rd.
Suffield,  CT  06078
Applicant Contact WILLIAM C NEALON
Correspondent
Biophysic Medical, Inc.
40 Crane Hill Rd.
Suffield,  CT  06078
Correspondent Contact WILLIAM C NEALON
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/25/1985
Decision Date 10/31/1985
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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