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510(k) K120769

MODULTH SLK by KARL STORZ Endoscopy-America, Inc. — Product Code LNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2012
Date Received
March 14, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Extracorporeal Shock-Wave, Urological
Device Class
Class II
Regulation Number
876.5990
Review Panel
GU
Submission Type

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Other clearances for product code LNS

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  • K201074 — Delta III Lithotripter (September 3, 2020)
  • K172084 — Delta III Lithotripter (August 8, 2017)
  • K170122 — Delta III Lithotripter (June 28, 2017)
  • K151298 — Gemini XXP-HP (July 30, 2015)
  • K142561 — LM-9300 ELMA Lithotripter (March 20, 2015)