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510(k) K033335

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS by Siemens Medical Solutions USA, Inc. — Product Code MMZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2003
Date Received
October 16, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Cystometric, Electric
Device Class
Class II
Regulation Number
876.4890
Review Panel
GU
Submission Type

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Other clearances for product code MMZ

  • K954278 — BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 (October 2, 1995)
  • K942445 — SYNERGY II (November 22, 1994)
  • K942485 — MDT UROLOGY TABLE (August 26, 1994)