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510(k) K895178

TECHNOMED PULSOLITH LASER SYSTEM by Teknomed, Inc. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
August 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

Other clearances by Teknomed, Inc.

  • K925395 — TECHNOMED PULSOLITH 4000 LASER SYSTEM (May 21, 1993)
  • K913917 — MULTILASE 2100 C, 2100 D (November 5, 1992)
  • K920708 — MULTILASE 2500 A (November 5, 1992)
  • K913290 — MULTILASE 2100 A (February 21, 1992)
  • K890436 — TECHNOMED PULSOLITH LASER SYSTEM (March 23, 1989)
  • K790132 — TECNOTOMO (February 21, 1979)

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  • K202813 — URO-TOUCH 9 French Probe (June 14, 2021)
  • K191124 — Swiss LithoClast Trilogy (May 29, 2019)
  • K162119 — UreTron PF Series Probe (August 29, 2016)
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  • K132795 — CYBERWAND STERILE PROBE SET (November 26, 2013)
  • K130368 — AUTOLITH TOUCH; URO TOUCH (November 15, 2013)
  • K123038 — SWISS LITHOBREAKER (January 16, 2013)