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510(k) K895775

CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM by Medtronic Vascular — Product Code KTB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1990
Date Received
September 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Specific Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type

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  • K974855 — PHORESOR II, MODEL PM900 (March 27, 1998)
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