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510(k) K082319

INJEKT FILIFORM INJECTION NEEDLE by Cook Urological, Inc. — Product Code FBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2008
Date Received
August 13, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.

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  • K082536 — COOK WIRE GUIDES (October 27, 2008)
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  • K073496 — OPTILITE HOLMIUM LASER FIBERS (January 23, 2008)
  • K072521 — COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH (November 20, 2007)
  • K061371 — SYDNEY IVF SPERM CRYOPRESERVATION BUFFER (August 17, 2006)
  • K060908 — SONOHYSTEROGRAPHY BIOPSY DEVICE (June 29, 2006)

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