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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K864331
Device Name TRI-LOCK LONG STEM MODULAR NECK
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact NANCY FRIDDLE
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact NANCY FRIDDLE
Date Received11/04/1986
Decision Date 01/06/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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