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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
510(k) Number K850165
Device Name MOTOR DRIVE, MECHANICAL SECTOR SCANNING-MOD417
Applicant
Hoffrel Instruments, Inc.
345 Wilson Ave.
P.O. Box 5825
South Norwalk,  CT  06854
Applicant Contact RUSSEL L UPHOFF
Correspondent
Hoffrel Instruments, Inc.
345 Wilson Ave.
P.O. Box 5825
South Norwalk,  CT  06854
Correspondent Contact RUSSEL L UPHOFF
Regulation Number870.2880
Classification Product Code
JOP  
Date Received01/16/1985
Decision Date 10/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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