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510(k) K840207

DOUBLE & SINGLE TANTALUM CLIPS by Storz Instrument Co. — Product Code HQW

K840207 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "DOUBLE & SINGLE TANTALUM CLIPS". The FDA issued a decision of Substantially Equivalent on March 29, 1984. The device falls under product code HQW (Clip, Tantalum, Ophthalmic), a Class II device regulated under 21 CFR 886.3100. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1984
Date Received
January 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Tantalum, Ophthalmic
Device Class
Class II
Regulation Number
886.3100
Review Panel
OP
Submission Type

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)

Other clearances for product code HQW

  • K897119 — GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP (April 12, 1990)
  • K901275 — RETINAL TAAK (March 23, 1990)

FDA data resources