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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K871648
Device Name TMJ CANNULA SET
Applicant
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155 -3936
Applicant Contact JOHNSON
Correspondent
Aspen Laboratories, Inc.
P.O. Box 3936
Englewood,  CO  80155 -3936
Correspondent Contact JOHNSON
Regulation Number872.4120
Classification Product Code
DZI  
Date Received04/28/1987
Decision Date 06/08/1987
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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