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510(k) K970994

CORE AND COIL ASSEMBLY GUIDEWIRE by Lake Region Mfg., Inc. — Product Code EZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1997
Date Received
March 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet For Catheter, Gastro-Urology
Device Class
Class I
Regulation Number
876.5130
Review Panel
GU
Submission Type

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  • K042338 — CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE (September 16, 2004)
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  • K040825 — LAKE REGION HYDROPHILIC GUIDEWIRE (May 17, 2004)

Other clearances for product code EZB

  • K971498 — APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (May 5, 1997)
  • K874164 — GUIDE WIRE (December 7, 1987)