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510(k) K003394

APPALEAD GW+03XXXXXXR SERIES by Nipro Medical Corp. — Product Code DQX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 30, 2001
Date Received: November 1, 2000
Clearance Type: Abbreviated
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Wire, Guide, Catheter
Device Class: Class II
Regulation Number: 870.1330
Review Panel: CV
Submission Type

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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)

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