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510(k) K010702

XUB EXTERNAL ULTRASOUND by Kmi Kolster Methods, Inc. — Product Code IMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2001
Date Received
March 8, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5300
Review Panel
PM
Submission Type

Other clearances by Kmi Kolster Methods, Inc.

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  • K012236 — STARS2000 POWER CANNULA (November 19, 2001)
  • K002859 — SSW-STERILE SOLUTION WARMER (November 16, 2000)
  • K991203 — IRRIGATION OR INFUSION PUMP K PUMP (October 15, 1999)

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