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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 K802146
Device Name AQUASONIC 100 ULTRASOUND TRANS. GEL,
Applicant
Parker Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Parker Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number892.1560
Classification Product Code
IYO  
Date Received09/05/1980
Decision Date 10/10/1980
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
Recalls CDRH Recalls
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