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510(k) K963675

THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE by Micro-Medical Devices, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1997
Date Received
September 13, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Micro-Medical Devices, Inc.

  • K003695 — MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5 (February 14, 2001)
  • K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL (March 15, 1999)
  • K951482 — ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE) (September 14, 1995)
  • K951894 — ACCESS EXPANSION SYSTEM (June 15, 1995)
  • K945656 — THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE (March 28, 1995)
  • K940141 — LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH (May 19, 1994)
  • K936213 — ARTHROSCOPES AND ACCESSORIES (May 18, 1994)

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  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)