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510(k) K843957

ULTRATHIN/SP LENS by Optical Systems Intl., Inc. — Product Code HRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1985
Date Received
October 10, 1984
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 by Optical Systems Intl., Inc.

  • K854218 — THE ULTRA-MATE LENS (November 12, 1985)

Other clearances for product code HRG

  • K013151 — ASMOTOM AUTOMATED TREPHINE SYSTEM (December 14, 2001)
  • K981063 — AUTOMATED CORNEAL TREPHINE (June 23, 1998)
  • 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)