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510(k) K800822

CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE by Kli — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1980
Date Received
April 14, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Kli

  • K800913 — GYNECOLOGICAL CYSTO/URETHROSCOPE (May 14, 1980)
  • K781913 — INSUFFALATOR LAPARAOSCOPIC (December 4, 1978)
  • K781109 — FORCEPS, ELECTROSURGICAL (September 14, 1978)
  • K781089 — ONE INCISION BI-POLAR ELECTRO. FORCEPS (July 17, 1978)
  • K780955 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K780954 — SCISSORS, HOOK, ELECTROSURGICAL (June 22, 1978)
  • K772297 — INSUFFLATOR, MODEL G100 & 200 (January 5, 1978)
  • K772242 — LAPAROSCOPY CONSOLE MODEL VIII (December 20, 1977)
  • K772220 — PROBE, COAGULATION ACCESSORY (December 13, 1977)
  • K772185 — LAPAROSCOPE W/REMOVABLE OPTICS (November 30, 1977)

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