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510(k) K100991

IMC SURGICAL DRAPE by International Medsurg Connection — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2010
Date Received
April 9, 2010
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 International Medsurg Connection

  • K110656 — IMC BLOOD COLLECTION NEEDLE (August 18, 2011)
  • K110882 — IMC INSULIN SYRINGE (August 18, 2011)
  • K102584 — IMC HYPODERMIC NEEDLE (January 14, 2011)
  • K102969 — IMC PISTON SYRINGES (December 20, 2010)
  • K100846 — IMC SURGICAL FACE MASK (August 16, 2010)
  • K100208 — IMC SURGICAL DRAPE (April 20, 2010)
  • K052169 — IMC SURGICAL DRAPES (November 17, 2005)
  • K042893 — UNDER BUTTOCKS DRAPE (March 11, 2005)
  • K023808 — IRRIGATION SETS (March 10, 2003)
  • K022159 — PISTON SYRINGE & HYPODERMIC NEEDLE (November 7, 2002)

Other clearances for product code KKX

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  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • 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)