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510(k) K813263

PATIENT UNDERPAD by The Buckeye Cellulose Corp. — Product Code KME

K813263 is an FDA 510(k) premarket notification submitted by The Buckeye Cellulose Corp. for the device "PATIENT UNDERPAD". The FDA issued a decision of Substantially Equivalent on November 27, 1981. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. The Buckeye Cellulose Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1981
Date Received
November 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
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)
  • K812962 — BOUNDARY SURGICAL DRAPE (November 20, 1981)
  • K812738 — BOUNDARY PROCESS CHANGE (November 16, 1981)

Other clearances for product code KME

  • K042145 — READY-HEAT BLANKET (September 17, 2004)
  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)

FDA data resources