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510(k) K833690

COAXIAL BALLOON URETHRAL DILATOR by American Edwards Laboratories — Product Code FAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1983
Date Received
October 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Replacer, Urethral
Device Class
Class III
Regulation Number
Review Panel
GU
Submission Type

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