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510(k) K932436

ECHOMARK INTRAUTERINE GUIDING CATHETER by Echocath, Inc. — Product Code MOV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1995
Date Received
May 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Salpingography
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K933417 — ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER (May 4, 1995)
  • K926351 — COLORMARK(TM) VISUALIZATION SYSTEM (September 16, 1993)
  • K922787 — ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION (January 6, 1993)

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  • K931476 — NOVY CORNUAL CANNULATION SET (July 28, 1995)
  • K931534 — OVAMED INTRAUTERINE ACCESS CATHETER (July 28, 1995)