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510(k) K936086

STERILE VIDEO CAMERA COVER AND DRAPE by Micromedical Devices, Inc. — Product Code KXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1994
Date Received
December 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Brachytherapy, Radionuclide
Device Class
Class II
Regulation Number
892.5730
Review Panel
RA
Submission Type

Other clearances by Micromedical Devices, Inc.

  • K043287 — PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 (December 10, 2004)
  • K936195 — LAPAROSCOPES (August 17, 1994)
  • K936155 — ADAIR INSUFFLATION AND INSTRUMENTATION CANNULA (April 11, 1994)
  • K936097 — VIDEO CAMERAS, ENCOSCOPIC AND SURGICAL (March 31, 1994)
  • K850791 — MDI 2000 - PULSE GENERATOR (June 19, 1985)
  • K834262 — TRANS-PACE (February 4, 1984)

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  • K221539 — GammaTile (November 9, 2022)
  • K202267 — Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge (December 31, 2020)
  • K193602 — LV Liberty Vision Model 1 90Yttrium Brachytherapy Source (May 29, 2020)
  • K190839 — GammaTile (January 23, 2020)
  • K191324 — CivaDerm (September 20, 2019)
  • K190296 — GammaTile (March 13, 2019)
  • K180515 — GammaTile (July 6, 2018)