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510(k) K993962

PENSIL TRAUMA, MODEL WWS6100 by Wuestec Medical, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
October 25, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Wuestec Medical, Inc.

  • K992603 — XRT 600 R/F, WRF 0600 (October 25, 1999)
  • K992103 — C-QUEST (September 1, 1999)
  • K981880 — DX-480, ADD ON DIGITAL IMAGER (October 20, 1998)
  • K974240 — LIGHTLINE-M (December 22, 1997)
  • K960083 — MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 (July 24, 1996)
  • K955414 — XRT 400 (July 24, 1996)
  • K935123 — SUPERSTAND 300 (March 27, 1996)
  • K933253 — SUPERSTAND 3000 (August 16, 1993)

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