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510(k) K112952

ILWAIT TIMER OCULOPRESSOR by Oryx Medical Pty, Ltd. — Product Code LCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2012
Date Received
October 5, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Ocular Pressure
Device Class
Class II
Regulation Number
886.4610
Review Panel
OP
Submission Type

Other clearances for product code LCC

  • K946194 — WEE BAG O'MERCURY (February 27, 1995)
  • K852032 — OCULAR PRESSURE REDUCER (MCCANNEL) (August 12, 1985)
  • K840004 — WEE BAG O'MERCURY (March 22, 1984)
  • K820526 — RELIEF VALVE-HONAN INTRAOC. PRESSURE (March 25, 1982)
  • K792255 — NEVYAS AUTOPRESS EYE COMPRESSOR (December 11, 1979)