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510(k) K081210

NIPRO SAFETOUCH HUBER INFUSTION SET by Nipro Medical Corp. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2008
Date Received
April 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Nipro Medical Corp.

  • K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (January 22, 2010)
  • K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A21 (October 4, 2007)
  • K063368 — NIPRO BIOHOLE NEEDLE (February 5, 2007)
  • K063721 — NIPRO SAFETOUCH II GAMMA (January 12, 2007)
  • K052474 — NIPRO HYPODERMIC NEEDLE (November 10, 2005)
  • K051574 — NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE (August 26, 2005)
  • K041779 — NIPRO DISPOSABLE STOPCOCKS, MODELS 3W-RC. NCN-3, 3W-R, 3W-L (September 21, 2004)
  • K032777 — MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE (November 14, 2003)
  • K030683 — NIPRO DISPOSABLE SYRINGES (October 31, 2003)
  • K022756 — NIPRO BIO-FLEX CATHETER (October 18, 2002)

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