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510(k) K931403

SITERITE NEEDLE GUIDE (MODIFIED) by Dymax Corp — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
March 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Dymax Corp

  • K032135 — SITE-RITE IV ULTRASOUND SYSTEM (July 21, 2003)
  • K993624 — SITE-RITE 3 ULTRASOUND SYSTEM (November 10, 1999)
  • 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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