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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 K901967
Device Name DENDIA WERK BURS AND CUTTING DISCS
Applicant
Micro-Aire Surgical Instruments, Inc.
24971 Ave. Stanford W.
Valencia,  CA  91355
Applicant Contact LEN LERITZ
Correspondent
Micro-Aire Surgical Instruments, Inc.
24971 Ave. Stanford W.
Valencia,  CA  91355
Correspondent Contact LEN LERITZ
Regulation Number872.4535
Classification Product Code
DZP  
Date Received05/01/1990
Decision Date 07/13/1990
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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