Home / 510(k) Clearances / K011498

510(k) K011498

EASY CONTROL MICRO INSERTER, MODEL ON385 by Ophtec USA, Inc. — Product Code NCE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2001
Date Received
May 15, 2001
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

Other clearances for product code NCE

  • K042478 — CAPSULE TENSION RING INSERTER, MODEL 7-810 (December 28, 2004)
  • K001125 — GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING (October 4, 2000)