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510(k) K980100

STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK by Storz Instrument Co. — Product Code MSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1998
Date Received
January 12, 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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Other clearances for product code MSR

  • K993361 — TUBING EXTENSION SET (January 4, 2000)
  • K983448 — ML UNIVERSAL TUBING (December 18, 1998)
  • K980849 — SURGIN KIT (July 9, 1998)
  • K972522 — ML-DISPOSABLE PAK (September 30, 1997)