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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K945500
Device Name WELLS JOHNSON FIXATION SYSTEM
Applicant
Wells Johnson Co.
075 E. Research Ct., Sut. 101
P. O. Box 18230
Tucson,  AZ  85733
Applicant Contact BRENDA HUNT
Correspondent
Wells Johnson Co.
075 E. Research Ct., Sut. 101
P. O. Box 18230
Tucson,  AZ  85733
Correspondent Contact BRENDA HUNT
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Codes
HRS   HWC  
Date Received11/09/1994
Decision Date 09/21/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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