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510(k) K083320

DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE by Dukal Corp. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2009
Date Received
November 12, 2008
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

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  • K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE (May 15, 2002)
  • K984564 — ETHYL CHLORIDE DISPENSER (December 2, 1999)
  • K970455 — DUKAL NON ADHERENT DRESSING (May 8, 1997)
  • K970457 — DUKAL ABD COMBINE PAD (May 8, 1997)
  • K955476 — DUKAL TRANSPARENT WOUND DRESSING (January 18, 1996)
  • K940440 — DUKAL NON-WOVEN GAUZE (March 9, 1994)
  • K936095 — GAUZE SPONGE (February 2, 1994)

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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)