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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 K014153
Device Name COAPT SYSTMES ENDOTINE DEVICE
Applicant
Coapt Systems, Inc.
261 Hamilton Ave.
Suite 413
Palo Alto,  CA  94301
Applicant Contact JUDE PAGANELLI
Correspondent
Coapt Systems, Inc.
261 Hamilton Ave.
Suite 413
Palo Alto,  CA  94301
Correspondent Contact JUDE PAGANELLI
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/18/2001
Decision Date 03/15/2002
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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