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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 K872098
Device Name CREMEEN ALVEOLAR BONE CALIPER
Applicant
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Applicant Contact SUSAN L BRANDT
Correspondent
Bowen & Company, Inc.
1800 Chapman Ave.
Rockville,  MD  20852
Correspondent Contact SUSAN L BRANDT
Regulation Number872.4565
Classification Product Code
EIL  
Date Received06/01/1987
Decision Date 07/31/1987
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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