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510(k) K941011

ACU-SIZER(TM) by Applied Medical Resources — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1994
Date Received
March 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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