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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal
510(k) Number K891482
Device Name AML(R) COLLARLESS LATERALIZED FEMORAL HIP
Applicant
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Applicant Contact BARRY R SISSON
Correspondent
Depuy, Inc.
P.O. Box 988
Warsaw,  IN  46581
Correspondent Contact BARRY R SISSON
Regulation Number888.3360
Classification Product Code
KWL  
Date Received03/17/1989
Decision Date 05/16/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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