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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 K023922
Device Name COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197
Applicant
Coapt Systems, Inc.
1152 Navarro St.
Santa Rosa,  CA  95401
Applicant Contact SHELLEY TRIMM
Correspondent
Coapt Systems, Inc.
1152 Navarro St.
Santa Rosa,  CA  95401
Correspondent Contact SHELLEY TRIMM
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/25/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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