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510(k) K891986

MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE by Mark One Healthcare Products — Product Code KME

K891986 is an FDA 510(k) premarket notification submitted by Mark One Healthcare Products for the device "MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE". The FDA issued a decision of Substantially Equivalent on December 29, 1989. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Mark One Healthcare Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1989
Date Received
March 28, 1989
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 Mark One Healthcare Products

  • K833867 — PAREMA K BAND NON-STERILE (January 27, 1984)
  • K833084 — MASTERHINGE (October 14, 1983)
  • K770396 — DRAPES, MODESTY (March 23, 1977)
  • K761268 — SKIN PRESSURE PROTECTORS (February 16, 1977)

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