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510(k) K961309

POS-T-VAC ID-300 by Pos-T-Vac, Inc. — Product Code KZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1996
Date Received
April 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Syringe Needle
Device Class
Class II
Regulation Number
880.6920
Review Panel
HO
Submission Type

Other clearances by Pos-T-Vac, Inc.

  • K020258 — SUPPORT SLEEVE (April 4, 2002)
  • K020154 — VT-1 (April 4, 2002)
  • K012672 — BOSS-2000-2 VACUUM ERECTION DEVICE (November 9, 2001)
  • K012670 — BOSS 2000-3 VACUUM ERECTION DEVICE (November 9, 2001)
  • K983245 — POS-T-VAC (AVP-1000) (November 2, 1998)
  • K983246 — POS-T-VAC (IVP-600) (November 2, 1998)
  • K981011 — POS-T-VAC (REJOYN VACUUM ERECTION DEVICE) (August 28, 1998)
  • K981180 — REJOYN CONSTRICTION RING KIT, POS-T-VAC B-100 RING KIT, POS-T-VAC B-25 RING KIT (August 28, 1998)
  • K960828 — POS-T-VAC B-10 BAND KIT (March 8, 1996)
  • K960342 — POS-T-VAC AVP-1000 & MVP-700 (March 1, 1996)

Other clearances for product code KZH

  • K243232 — GripMate (December 2, 2024)
  • K213429 — AccuSert Needle Inserter (October 20, 2022)
  • K163400 — Orbit Inserter (July 26, 2017)
  • K160860 — MiniMed Quick-serter (September 22, 2016)
  • K141384 — WHISPERJECT AUTOINJECTOR (September 12, 2014)
  • K124026 — LOBSTER AUTO-INJECTOR (September 13, 2013)
  • K122837 — AUTOJECT 2 FOR GLASSY SYRINGE (October 15, 2012)
  • K111467 — FLEXI-Q DV AND DVR AUTO-INJECTORS (February 9, 2012)
  • K082587 — AUTO-SAFETY INJECTOR-2 (ASI-2) (October 2, 2008)
  • K073476 — COMPACT AUTO-SAFETY INJECTOR (CASI) (March 7, 2008)