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510(k) K900638

P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT by Johnson & Johnson International — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1990
Date Received
February 9, 1990
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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  • K895207 — BIOCLUSIVE* TRANSPARENT FILM DRESSING - NEW CLAIM (September 28, 1989)

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