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510(k) K884380

BED SHEET, PILLOW CASE by Saybrex Intl., Inc. — Product Code KME

K884380 is an FDA 510(k) premarket notification submitted by Saybrex Intl., Inc. for the device "BED SHEET, PILLOW CASE". The FDA issued a decision of Substantially Equivalent on November 8, 1988. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Saybrex Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1988
Date Received
October 18, 1988
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 Saybrex Intl., Inc.

  • K884295 — SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE (November 8, 1988)

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