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510(k) K993361

TUBING EXTENSION SET by Hurricane Medical — Product Code MSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2000
Date Received
October 6, 1999
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

Other clearances by Hurricane Medical

  • K990672 — LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET (May 18, 1999)
  • K990671 — DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIP (May 10, 1999)

Other clearances for product code MSR

  • K983448 — ML UNIVERSAL TUBING (December 18, 1998)
  • K980849 — SURGIN KIT (July 9, 1998)
  • K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK (June 1, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)