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510(k) K864056

GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT by Grieshaber & Co. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1986
Date Received
October 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Grieshaber & Co.

  • K950056 — THE GRIESHABER AXIAL CUTTER (May 5, 1995)
  • K930842 — THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE (May 3, 1994)
  • K914588 — GRIESHABER SNARE INSTRUMENT AND SNARE CARTRIDGE (June 11, 1992)
  • K914587 — GRIESHABER AIR/FLUID TUBING SET (January 23, 1992)
  • K914586 — GRIESHABER THREE FUNCTION MANIPULATOR (January 3, 1992)
  • K914585 — GRIESHABER TWO FUNCTION MANIPULATOR (January 3, 1992)
  • K897119 — GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP (April 12, 1990)
  • K900714 — ZZIPP INSTANT BOVIE CLEANER (March 27, 1990)
  • K890782 — GRIESHABER SOFT TIP NEEDLE (20 & 19 GAUGES) (June 23, 1989)
  • K890783 — GRIESHABER VISCOELASTIC INJECTION SYSTEM (May 16, 1989)

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