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510(k) K030908

DEROYAL SURGICAL DRAPES BACKTABLE COVER by Deroyal — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2003
Date Received
March 24, 2003
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 Deroyal

  • K041416 — EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER (July 2, 2004)
  • K033057 — DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE (November 20, 2003)
  • K031408 — DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) (October 15, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)

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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)