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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, And Accessories, Dental
510(k) Number K050735
Device Name MC6A
Applicant
Macan Engineering Co.
1564 N. Damen Ave.
Chicago,  IL  60622
Applicant Contact RICH GARRETT
Correspondent
Macan Engineering Co.
1564 N. Damen Ave.
Chicago,  IL  60622
Correspondent Contact RICH GARRETT
Regulation Number872.4920
Classification Product Code
EKZ  
Date Received03/21/2005
Decision Date 05/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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