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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K051293
Device Name CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM
Applicant
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Applicant Contact TADEUSZ WELLISZ
Correspondent
Ceremed , Inc.
3643 Lenawee Ave.
Los Angeles,  CA  90016
Correspondent Contact TADEUSZ WELLISZ
Regulation Number872.4760
Classification Product Code
JEY  
Date Received05/18/2005
Decision Date 06/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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