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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 K911930
Device Name STERILE PACKAGED POWER INSTRUMENT ACCESSORIES
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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