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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K880621
Device Name CAPCADDY
Applicant
Capcad, Inc.
P.O. Box 3092
Winnipeg, Manitoba
Canada,  CA R3C 4E5
Applicant Contact MAJA J WILLOUGHBY
Correspondent
Capcad, Inc.
P.O. Box 3092
Winnipeg, Manitoba
Canada,  CA R3C 4E5
Correspondent Contact MAJA J WILLOUGHBY
Regulation Number872.6770
Classification Product Code
EJI  
Date Received02/16/1988
Decision Date 04/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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