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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 K991964
Device Name EIS THREADED SCREW FRACTURE FIXATION
Applicant
Groupe Lepine
962 S. Tamiami Trl. Suite 203
Sarasota,  FL  34326
Applicant Contact DOUGLAS W STUART
Correspondent
Groupe Lepine
962 S. Tamiami Trl. Suite 203
Sarasota,  FL  34326
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/10/1999
Decision Date 12/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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