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510(k) K821564

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
May 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
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)
  • 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)
  • K812738 — BOUNDARY PROCESS CHANGE (November 16, 1981)

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