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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Hemi-, Phalangeal
510(k) Number K861983
Device Name SUTTER LESSER METATARSAL CAP
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 Number888.3730
Classification Product Code
KWD  
Date Received05/22/1986
Decision Date 09/08/1986
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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