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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K022535
Device Name MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
Applicant
Microtech
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GRACE HOLLAND
Correspondent
Microtech
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GRACE HOLLAND
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/31/2002
Decision Date 10/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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