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510(k) K993624

SITE-RITE 3 ULTRASOUND SYSTEM by Dymax Corp — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1999
Date Received
October 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Dymax Corp

  • K032135 — SITE-RITE IV ULTRASOUND SYSTEM (July 21, 2003)
  • K931403 — SITERITE NEEDLE GUIDE (MODIFIED) (July 27, 1993)
  • K903158 — SITERITE NEEDLE GUIDE (September 27, 1990)
  • K894415 — DYMAX ENDOVAGINAL BIOPSY GUIDE (October 25, 1989)
  • K862127 — DYMAX PERSONAL SCANNER (December 11, 1986)
  • K850478 — PLUS 1 (April 15, 1985)

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