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510(k) K023227

USG 2000SA by Ultraguide , Ltd. — Product Code HHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2002
Date Received
September 27, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.2225
Review Panel
OB
Submission Type

Other clearances by Ultraguide , Ltd.

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  • K002258 — ULTRAGUIDE CT-GUIDE 1010 (August 8, 2000)
  • K974432 — ULTRAGUIDE 1000 (February 9, 1998)