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510(k) K962761

REIGEL TUNNELING DEVICE by Cook, Inc. — Product Code GYK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1996
Date Received
July 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Shunt System Implantation
Device Class
Class I
Regulation Number
882.4545
Review Panel
NE
Submission Type

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Other clearances for product code GYK

  • K934391 — V/P AND L/P CATHETER PASSERS (November 19, 1993)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (September 10, 1993)
  • K932273 — CORDIS TUNNELER (August 23, 1993)
  • K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (October 31, 1989)
  • K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (September 30, 1988)
  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (January 13, 1987)
  • K853370 — H-H CATHETER PASSERS(TACL DESIGN (September 18, 1985)
  • K853368 — H-H SHUNT INTRODUCER (September 6, 1985)
  • K841553 — H-H SHUNT PASSERS (May 14, 1984)