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510(k) K943393

CIVCO PROBE BOOT/CORD COVER by CIVCO Medical Instruments Co., Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1995
Date Received
July 14, 1994
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 CIVCO Medical Instruments Co., Inc.

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  • K080072 — MRI PATIENT POSITIONING DEVICES (June 4, 2008)
  • K013721 — SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (December 28, 2001)
  • K002546 — CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE (October 31, 2000)

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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)