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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Cartridge
510(k) Number K904278
Device Name HOLDER, DENTAL BUR, ALUMINUM
Applicant
Maverick Surgical, Inc.
16940 - 87 Ave.
Edmonton, Alberta,  CA T5R 4H5
Applicant Contact KEN KEHOE
Correspondent
Maverick Surgical, Inc.
16940 - 87 Ave.
Edmonton, Alberta,  CA T5R 4H5
Correspondent Contact KEN KEHOE
Regulation Number872.6770
Classification Product Code
EJI  
Date Received09/17/1990
Decision Date 11/02/1990
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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