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510(k) K954253

STORZ S2060-C & DP9040 BIPOLAR CCORD ADAPTORS by Storz Instrument Co. — Product Code GEI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1995
Date Received
September 11, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Storz Instrument Co.

  • K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK (June 1, 1998)
  • 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)

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