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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 K870200
Device Name SUTTER FINGER JOINT PROSTHESIS
Applicant
Sutter Biomedical, Inc.
3940 Ruffin Rd.
San Diego,  CA  92123
Applicant Contact MIZOGUCHI, PHD
Correspondent
Sutter Biomedical, Inc.
3940 Ruffin Rd.
San Diego,  CA  92123
Correspondent Contact MIZOGUCHI, PHD
Regulation Number888.3230
Classification Product Code
KYJ  
Date Received01/20/1987
Decision Date 10/09/1987
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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