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510(k) K042478

CAPSULE TENSION RING INSERTER, MODEL 7-810 by Duckworth & Kent, Ltd. — Product Code NCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2004
Date Received
September 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector, Capsular Tension Ring
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

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  • K060995 — DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788 (May 22, 2006)
  • K053176 — DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 (January 30, 2006)
  • K024072 — DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM (October 6, 2003)

Other clearances for product code NCE

  • K011498 — EASY CONTROL MICRO INSERTER, MODEL ON385 (July 9, 2001)
  • K001125 — GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (October 4, 2000)