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510(k) K882494

ELAN-E DISPOSALBE DRAPE by Dermacare Products, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
June 16, 1988
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 Dermacare Products, Inc.

  • K882421 — INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE (June 30, 1988)
  • K871910 — SURGITEK DISPOSABLE BIPOLAR CORD (June 1, 1987)
  • K863280 — DERMAMARKER (September 9, 1986)
  • K863279 — SURGI-TEK TUBE POSITIONER (September 9, 1986)
  • K863278 — SURGI-WIPES (September 2, 1986)
  • K862367 — PRO-CLEAN (July 8, 1986)
  • K853374 — CORRECT-A-COUNT (September 5, 1985)

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)