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510(k) K904186

SITE DIAPHRAGM CASSETTE by Site Microsurgical Systems, Inc. — Product Code KYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1990
Date Received
September 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Irrigation, Ocular Surgery
Device Class
Class I
Regulation Number
886.4360
Review Panel
OP
Submission Type

Other clearances by Site Microsurgical Systems, Inc.

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  • K925921 — MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE (December 6, 1993)
  • K931866 — SITE'S CD II PHACOEMULSIFICATION HANDPIECE (November 12, 1993)
  • K921135 — IOLAB POWER I.V. POLE (June 3, 1992)
  • K920582 — 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT. (May 8, 1992)
  • K912902 — PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE (December 17, 1991)
  • K912739 — SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE (August 28, 1991)
  • K910980 — SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE (May 22, 1991)
  • K905620 — MODIFIED SITE PERISTALTIC FOOTSWITCH (February 27, 1991)
  • K904183 — SITE PHACOEMULSIFICATION HANDPIECE (December 5, 1990)

Other clearances for product code KYG

  • K010353 — MED-LOGICS DISPOSABLE ALK TUBING (April 27, 2001)
  • K003036 — TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,10102 (December 22, 2000)
  • K993591 — BLADEWORKS DISPOSABLE ALK TUBING (December 28, 1999)
  • K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM (May 19, 1998)
  • K980647 — EYE IRRIGATOR MODEL #2020 (May 15, 1998)
  • K974561 — MOISTAIR FLUID AIR TUBING SET (February 19, 1998)
  • K971173 — ML DISPOSABLE ALK TUBING (May 22, 1997)
  • K970161 — HEDGES CORNEAL WETTING PAK (March 25, 1997)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K945171 — DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE (February 8, 1995)