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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 K041835
Device Name ENDOTINE MIDFACE B 4.5 DEVICE
Applicant
Coapt Systems, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact LORI DONDIEGO
Correspondent
Coapt Systems, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Correspondent Contact LORI DONDIEGO
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
GAN  
Date Received07/07/2004
Decision Date 09/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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