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510(k) K002279

ML EYE SPEAR, MODEL ML 27 ES by Med-Logics, Inc. — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2000
Date Received
July 26, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Med-Logics, Inc.

  • K033293 — MED-LOGICS, MODEL ML7090 (January 13, 2004)
  • K022982 — MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB (November 15, 2002)
  • K022716 — MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB (October 11, 2002)
  • K010872 — ML BLADE, MODEL ML7030 (June 22, 2001)
  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K002515 — MEDLOGICS ML 4000, MODEL 4000 (February 22, 2001)
  • K983448 — ML UNIVERSAL TUBING (December 18, 1998)
  • K981071 — ML MICROKERATOME (July 23, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)

Other clearances for product code HOZ

  • K132796 — SUNTOUCH EYE SPEAR (October 30, 2013)
  • K130117 — NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS (October 29, 2013)
  • K091240 — ALPHAMED SURGICAL SPEAR, MODEL 70-5000 (October 23, 2009)
  • K082460 — CENEFOM PVA SURGICAL SPEAR (December 15, 2008)
  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K011191 — MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES (June 26, 2001)
  • K003842 — PRESCOTT'S SURGICAL SPEAR (April 13, 2001)
  • K993883 — M-PACT CORNEAL LIGHT SHIELD (December 21, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)
  • K990749 — SOF-SUCTION FLUID EVACUATION SYSTEM (April 2, 1999)