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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K864508
Device Name HOWSE II TOTAL HIP REPLACEMENT SYSTEM
Applicant
Johnson & Johnson Professionals, Inc.
Brunel Way
Slough, Berks
England,  GB SL1 IXR
Applicant Contact ALISON J HOWITT
Correspondent
Johnson & Johnson Professionals, Inc.
Brunel Way
Slough, Berks
England,  GB SL1 IXR
Correspondent Contact ALISON J HOWITT
Date Received11/14/1986
Decision Date 12/09/1986
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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