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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 K931588
FOIA Releasable 510(k) K931588
Device Name SUTTER PROXIMAL INTERPHALANGEAL JOINT
Applicant
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact LOUISE M FOCHT
Correspondent
Sutter Corp.
9425 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact LOUISE M FOCHT
Regulation Number888.3230
Classification Product Code
KYJ  
Date Received03/31/1993
Decision Date 03/10/1994
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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