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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Diamond, Dental
510(k) Number K913651
Device Name MANI DIA-BURS
Applicant
The Lahr Consulting Group, Inc.
One Lethbridge Plz.
Suite 4
Mahwah,  NJ  07430
Applicant Contact BRENDA M KELLY
Correspondent
The Lahr Consulting Group, Inc.
One Lethbridge Plz.
Suite 4
Mahwah,  NJ  07430
Correspondent Contact BRENDA M KELLY
Regulation Number872.4535
Classification Product Code
DZP  
Date Received08/16/1991
Decision Date 01/14/1992
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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