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510(k) K812738

BOUNDARY PROCESS CHANGE by The Buckeye Cellulose Corp. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
September 29, 1981
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 The Buckeye Cellulose Corp.

  • K822925 — BOUNDARY SINGLE-USE GOWNS (January 12, 1983)
  • K823173 — ARRIRM SCRUB BRUSH/SPONGE (November 22, 1982)
  • K821564 — BOUNDARY PROCESS CHANGE (July 2, 1982)
  • K820758 — BOUNDARY SINGLE-USE CRANIOTOMY SHEET (April 29, 1982)
  • K820116 — BOUNDARY (February 23, 1982)
  • K813450 — BOUNDARY SINGLE-USE DRAPES (January 22, 1982)
  • K813390 — BONDARY SINGLE-USE OR GOWN (January 5, 1982)
  • K813277 — BOUNDARY DRAPE TAPE (December 18, 1981)
  • K813263 — PATIENT UNDERPAD (November 27, 1981)
  • K812962 — BOUNDARY SURGICAL DRAPE (November 20, 1981)

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)