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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, Diagnostic
510(k) Number K963169
Device Name RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL
Applicant
Rapid-Aid Ltd./Ltee
4-3345 Laird Rd.
Mississuaga,Ontario,  CA L5L 5R6
Applicant Contact GEORGE SCHMIDT
Correspondent
Rapid-Aid Ltd./Ltee
4-3345 Laird Rd.
Mississuaga,Ontario,  CA L5L 5R6
Correspondent Contact GEORGE SCHMIDT
Regulation Number892.1570
Classification Product Code
ITX  
Date Received08/14/1996
Decision Date 11/12/1996
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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