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510(k) K905017

LAB-SITE by Telos Medical Corp. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1991
Date Received
November 7, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
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)
  • K914387 — TRANSCERVICAL INTRAUTERINE KIT (December 30, 1991)
  • K905018 — LAB-SITE SAFETY NEEDLE (January 16, 1991)
  • K882224 — ULTRANS DISPOSABLE INTRAUTERINE (October 12, 1989)
  • K883832 — CATHETER, INTRAUTERINE AND INTRODUCER (December 13, 1988)

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