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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, Constrained, Polymer
510(k) Number K943354
Device Name SUTTER HAMMERTOE JOINT PROSTHESIS
Applicant
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact LOUISE FOCHT
Correspondent
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact LOUISE FOCHT
Regulation Number888.3720
Classification Product Code
KWH  
Date Received07/12/1994
Decision Date 06/12/1995
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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