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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, Obstetric
510(k) Number K871856
Device Name ANNULAR ARRAY SCANHEAD
Applicant
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Applicant Contact JOHN DELLINGER
Correspondent
ADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98041 -3003
Correspondent Contact JOHN DELLINGER
Regulation Number884.2960
Classification Product Code
HGL  
Date Received05/12/1987
Decision Date 08/28/1987
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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