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510(k) K894883

PHYCON ALL SILICONE BALLOON CATHETER by Vitaid, Ltd. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
August 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Retention Type, Balloon
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K894337 — UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM (September 29, 1989)

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