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510(k) K971328

OLYMPUS CD-6C-1 COAGULATION ELECTRODE by Olympus America, Inc. — Product Code FFE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1997
Date Received
April 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Water Jet Catheter, Renal
Device Class
Class II
Regulation Number
876.4650
Review Panel
GU
Submission Type

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