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510(k) K914387

TRANSCERVICAL INTRAUTERINE KIT by Telos Medical Corp. — Product Code HGS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1991
Date Received
October 1, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intrauterine And Introducer
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

Other clearances by Telos Medical Corp.

  • K920375 — DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (October 27, 1992)
  • K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (April 3, 1992)
  • K905018 — LAB-SITE SAFETY NEEDLE (January 16, 1991)
  • K905017 — LAB-SITE (January 15, 1991)
  • K882224 — ULTRANS DISPOSABLE INTRAUTERINE (October 12, 1989)
  • K883832 — CATHETER, INTRAUTERINE AND INTRODUCER (December 13, 1988)

Other clearances for product code HGS

  • K905812 — INTRAUTERINE CATHETER SET (January 31, 1991)