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510(k) K980849

SURGIN KIT by Surgin Surgical Instrumentation, Inc. — Product Code MSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1998
Date Received
February 5, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Replacement, Phacofragmentation Unit
Device Class
Class II
Regulation Number
886.4150
Review Panel
OP
Submission Type

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  • 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)
  • K954238 — SURGIN GENISIS HANDPIECE (December 8, 1995)
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  • K942945 — CASSETTE SYSTEM FOR STORZ (December 5, 1994)
  • K942944 — IRRIGATION/BIPOLAR SET (September 27, 1994)
  • K942897 — OPTHALMIC WIPE (August 5, 1994)

Other clearances for product code MSR

  • K993361 — TUBING EXTENSION SET (January 4, 2000)
  • K983448 — ML UNIVERSAL TUBING (December 18, 1998)
  • K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK (June 1, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)