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510(k) K991097

PBN DRAINAGE CATHETER GUIDEWIRES by Medical Device Technologies, Inc. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1999
Date Received
April 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K031442 — PBN GUIDEWIRES (August 13, 2003)
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  • K011790 — MICROCRUISER PLUS INTRODUCER SET (September 5, 2001)

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