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510(k) K970185

STERILE DISPOSABLE EQUIPMENT MAGNET COVER by Contour Fabricators, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1997
Date Received
January 17, 1997
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 Contour Fabricators, Inc.

  • K090773 — CFI ULTRASOUND PROBE DRAPE (September 18, 2009)
  • K970900 — INSTRUMENT HOLDER (May 22, 1997)
  • K971040 — CABLE HOLDER, SUCTION TUBE HOLDER (April 16, 1997)
  • K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER (January 30, 1997)
  • K963453 — CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) (November 15, 1996)
  • K820692 — BANDBAG, WRAP, STERILE (May 3, 1982)
  • K782155 — GENERAL EQUIPMENT COVER (January 17, 1979)

Other clearances for product code KKX

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  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • 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)