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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K961905
Device Name MEDICINELODGE, INC. SET SCREW
Applicant
MEDICINE LODGE, INC.
152 SOUTH 600 WEST
LOGAN,  UT  84321
Applicant Contact WADE F ALLIN
Correspondent
MEDICINE LODGE, INC.
152 SOUTH 600 WEST
LOGAN,  UT  84321
Correspondent Contact WADE F ALLIN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/16/1996
Decision Date 08/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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