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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 K881336
Device Name BRYMASCAN-A
Applicant
Brymill Corp.
P.O. Box 2392
Vernon,  CT  06066
Applicant Contact MICHAEL D BRYNE
Correspondent
Brymill Corp.
P.O. Box 2392
Vernon,  CT  06066
Correspondent Contact MICHAEL D BRYNE
Regulation Number892.1560
Classification Product Code
IYO  
Date Received03/29/1988
Decision Date 03/14/1989
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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