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510(k) K961290

IUP - TIP TRANS, IUP - PROXI TRANS by Scientific Device Manufacturer, LLC — Product Code KXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1996
Date Received
April 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

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  • K960430 — CONTROL SYRINGE (August 6, 1996)
  • K960917 — PERCUGLIDE (July 2, 1996)
  • K952579 — TOCO TRANSDUCER (August 4, 1995)

Other clearances for product code KXO

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  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 1998)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER (July 24, 1995)
  • K950708 — LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 (May 25, 1995)
  • K922323 — MX4042/MC4044 SERIES SIMULCATH(TM) (June 14, 1994)
  • K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (April 3, 1992)
  • K910742 — MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER (January 14, 1992)
  • K905563 — INTRAN PLUS (June 19, 1991)