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510(k) K822687

REUSABLE FOGARTY FLEXIBLE CALIBRATOR by American Edwards Laboratories — Product Code DWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1982
Date Received
September 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, Surgical
Device Class
Class II
Regulation Number
870.4475
Review Panel
CV
Submission Type

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  • K864155 — MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (November 20, 1986)
  • K863986 — XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (October 31, 1986)

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