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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K952766
Device Name RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)
Applicant
Creative Medical Designs, Inc.
13914 Shady Shores Dr.
Tampa,  FL  33613
Applicant Contact JOHN M RAYHACK
Correspondent
Creative Medical Designs, Inc.
13914 Shady Shores Dr.
Tampa,  FL  33613
Correspondent Contact JOHN M RAYHACK
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/31/1995
Decision Date 12/13/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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