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510(k) K864984

ROBINJECT by International Medical Products, Inc. — Product Code KZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1987
Date Received
December 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Fluid, Non-Electrically Powered
Device Class
Class II
Regulation Number
880.5430
Review Panel
HO
Submission Type

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  • K973253 — ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE (October 30, 1997)
  • K971053 — ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE D (June 16, 1997)
  • K920077 — NIKKISO NK PUMP (September 29, 1993)
  • K923942 — RHOMBO MEDICAL RHOMBO-FILL (March 24, 1993)
  • K900755 — DIGITAL CUFF PV GAUGE (April 26, 1990)
  • K863609 — SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22 (February 25, 1987)
  • K861539 — NIKKISO INFUSION PUMP MODEL PFA-02 (July 31, 1986)

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  • K110456 — PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM (March 2, 2011)
  • K090959 — LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA (December 24, 2009)
  • K090003 — ZETAJET (April 2, 2009)
  • K081532 — PHARMAJET NEEDLE-FREE INJECTION SYSTEM (February 26, 2009)
  • K082138 — AIRGENT, MODEL AG7000010 (January 23, 2009)
  • K060819 — COOL.CLICK 2 (June 16, 2006)
  • K051985 — BIOVALVE MINI-JECT NEEDLEFREE INJECTOR (August 17, 2005)
  • K050734 — COOL.CLICK (June 3, 2005)