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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K941009
Device Name DISPOSABLE PROPHY ANGLE
Applicant
Allpro, Inc.
P.O. Box 733
Broomfield,  CO  80038
Applicant Contact JANET JENSEN
Correspondent
Allpro, Inc.
P.O. Box 733
Broomfield,  CO  80038
Correspondent Contact JANET JENSEN
Regulation Number872.4200
Classification Product Code
EGS  
Date Received03/01/1994
Decision Date 06/06/1994
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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