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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 K885075
Device Name ABIOMED PERIOTEMP(TM) PROBE
Applicant
Abiomed, Inc.
33 Cherry Hill Dr.
Danvers,  MA  01923
Applicant Contact PARAM I SINGH
Correspondent
Abiomed, Inc.
33 Cherry Hill Dr.
Danvers,  MA  01923
Correspondent Contact PARAM I SINGH
Regulation Number872.4565
Classification Product Code
EIL  
Date Received12/08/1988
Decision Date 02/13/1989
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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