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510(k) K013151

ASMOTOM AUTOMATED TREPHINE SYSTEM by Bkg Opthalmics USA, Inc. — Product Code HRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2001
Date Received
September 20, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Engine, Trephine, Accessories, Ac-Powered
Device Class
Class I
Regulation Number
886.4070
Review Panel
OP
Submission Type

Other clearances for product code HRG

  • K981063 — AUTOMATED CORNEAL TREPHINE (June 23, 1998)
  • K843957 — ULTRATHIN/SP LENS (July 31, 1985)
  • K841515 — SCANLAN VASCU-STATT II (June 5, 1984)
  • K823901 — TREPHINE BLADES-VARIOUS MODELS (January 17, 1983)
  • K791763 — (MICRO-KERATRON, MICRO DUCT TREPHINE) (November 5, 1979)