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510(k) K033236

PRIZM KERATOME BLADE, MODEL MK8512M2 by Surgin Surgical Instrumentation, Inc. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2004
Date Received
October 6, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Surgin Surgical Instrumentation, Inc.

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  • K033182 — PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD (January 30, 2004)
  • K011195 — PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511 (November 6, 2001)
  • K994015 — ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (March 15, 2000)
  • K980849 — SURGIN KIT (July 9, 1998)
  • K954238 — SURGIN GENISIS HANDPIECE (December 8, 1995)
  • K950600 — VACUUM SURGE SUPRESSER (May 10, 1995)
  • K942945 — CASSETTE SYSTEM FOR STORZ (December 5, 1994)
  • K942944 — IRRIGATION/BIPOLAR SET (September 27, 1994)
  • K942897 — OPTHALMIC WIPE (August 5, 1994)

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  • K082043 — CARRIAZO-PENDULAR MICROKERATOME (August 1, 2008)
  • K062465 — ZYOPTIX XP EPI SEPARATOR SYSTEM (September 6, 2006)
  • K052891 — HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM (March 23, 2006)
  • K051486 — NORWOOD ABBEY CENTURION SES EPIKERATOME (July 6, 2005)
  • K043183 — EPI-K (March 25, 2005)
  • K043150 — AMADEUS II EPIKERATOME (January 31, 2005)
  • K042083 — MODIFICATION TO VISITOME 20-10 MICROKERATOME (November 16, 2004)