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510(k) K980100

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

K980100 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK". The FDA issued a decision of Substantially Equivalent on June 1, 1998. The device falls under product code MSR (Tubing, Replacement, Phacofragmentation Unit), a Class II device regulated under 21 CFR 886.4150. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

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

Other clearances by Storz Instrument Co.

  • K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM (March 23, 1998)
  • K972664 — STORZ MILLENNIUM VISCOUS FLUID SYSTEM (October 10, 1997)
  • K971439 — STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES (June 17, 1997)
  • K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR (February 3, 1997)
  • K960024 — STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE (September 20, 1996)
  • K960061 — STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE (September 18, 1996)
  • K960003 — STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (August 29, 1996)
  • K962131 — STORZ D4600 AIR EXCHANGE LINE PACK (August 23, 1996)
  • K961874 — STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK (August 6, 1996)
  • K961831 — STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK (August 6, 1996)

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)

FDA data resources