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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K103157
Device Name DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE
Applicant
Angstrom Mfg., Inc.
6539 U.S. Hwy. 61
Bloomsdale,  MO  63627
Applicant Contact CHRIS CARRON
Correspondent
Angstrom Mfg., Inc.
6539 U.S. Hwy. 61
Bloomsdale,  MO  63627
Correspondent Contact CHRIS CARRON
Regulation Number872.4200
Classification Product Code
EGS  
Date Received10/26/2010
Decision Date 01/24/2011
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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