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510(k) K965198

ULTIMA TPS CEMENTED STEM by Johnson & Johnson International — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1997
Date Received
December 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

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  • K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING (November 21, 1990)
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  • K900638 — P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT (April 30, 1990)
  • K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (September 28, 1989)

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