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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K911929
Device Name SMALL BONE FIXATION SYSTEM
Applicant
United American Medical Co., Inc.
216 E. Main St.
P.O. Box 308
Mc Minnville,  TN  37110
Applicant Contact THOMAS L WALLING
Correspondent
United American Medical Co., Inc.
216 E. Main St.
P.O. Box 308
Mc Minnville,  TN  37110
Correspondent Contact THOMAS L WALLING
Regulation Number878.4820
Classification Product Code
HWE  
Date Received04/30/1991
Decision Date 07/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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