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510(k) K845023

STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000 by Storz Instrument Co. — Product Code LGX

K845023 is an FDA 510(k) premarket notification submitted by Storz Instrument Co. for the device "STORZ PLASTIC SURGERY & EXAMINATION LOUNGE 7000". The FDA issued a decision of Substantially Equivalent on January 28, 1985. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Storz Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1985
Date Received
December 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Examination, Medical, Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
HO
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 LGX

  • K945163 — ECHOCARDIOGRAPHY (February 17, 1995)
  • K894144 — POWER EXAMINATION TABLE MODEL # 405 (August 28, 1989)
  • K894134 — POWER EXAMINATION TABLE MODEL # 411 (August 28, 1989)
  • K883680 — MEDALIST EXAMINATION TABLE (October 4, 1988)
  • K882010 — POWER EXAMINATION TABLE (July 13, 1988)
  • K864072 — ADEC 1005-C CHAIR (November 7, 1986)
  • K860519 — RELIANCE MODEL 200 PODIATRY CHAIR (February 19, 1986)
  • K830294 — MEDICAL EXAM TABLE (January 11, 1984)
  • K832768 — S & W SW52E W/POWER BACK LIFT (September 20, 1983)
  • K820823 — MULTIPLE, MODEL #17 (April 21, 1982)

FDA data resources