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510(k) K032777

MODIFICATION TO: NIPRO SAFE TOUCH SAFETY FISTULA NEEDLE by Nipro Medical Corp. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2003
Date Received
September 8, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Nipro Medical Corp.

  • K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE (January 22, 2010)
  • K081210 — NIPRO SAFETOUCH HUBER INFUSTION SET (October 21, 2008)
  • 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)
  • K030683 — NIPRO DISPOSABLE SYRINGES (October 31, 2003)
  • K022756 — NIPRO BIO-FLEX CATHETER (October 18, 2002)

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