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510(k) K971682

J-FX CERCLAGE SYSTEM by Johnson & Johnson Professionals, Inc. — Product Code LRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1997
Date Received
May 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Surgical
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K980801 — J-FX BIPOLAR HEAD (May 29, 1998)

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