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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauge, Depth, Instrument, Dental
510(k) Number K911643
Device Name ABIODENT PERIOTEMP(R) SYSTEM
Applicant
Abiomed, Inc.
33 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact BRUCE J SHOOK
Correspondent
Abiomed, Inc.
33 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact BRUCE J SHOOK
Regulation Number872.4565
Classification Product Code
EIL  
Date Received04/12/1991
Decision Date 07/09/1991
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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