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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Finger, Constrained, Polymer
510(k) Number K781668
Device Name GAMMA RADIATION STERILIZATION PRECEDURE
Applicant
Cutter Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cutter Laboratories, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3230
Classification Product Code
KYJ  
Date Received09/28/1978
Decision Date 11/03/1978
Decision Substantially Equivalent (SESE)
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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