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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K860074
Device Name SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS
Applicant
Warsaw Orthopedic, Inc.
755 Crossover Ln.
Memphis,  TN  38117
Applicant Contact JAMES RITTER
Correspondent
Warsaw Orthopedic, Inc.
755 Crossover Ln.
Memphis,  TN  38117
Correspondent Contact JAMES RITTER
Date Received01/07/1986
Decision Date 02/11/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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