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510(k) K881878

CATHETER WITHDRAWAL UNIT by Eris Medical Technology — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
May 4, 1988
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

Other clearances by Eris Medical Technology

  • K882295 — FILLING VOLUME OPTION (September 13, 1988)
  • K850169 — ERIS URO-DIAGNOSTIC SYSTEM (April 22, 1985)

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